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Issues (investigated or analyzed)

The Medtronic's Enpulse Model E2DR21P Serial number PMU411109 as well as the Atrial Lead (model #496525, SN: LBT042477R-Epicardial Unipolar and the Ventricular Lead (model #496525, SN: LEN036731R- Bipolar Epicardial had been used to continually pace patient in the DDD pacing mode during patient's lifetime. The expert referred to all Medtronic specifications; warnings; and advisories relevant to both the pacemaker and pacing leads used for pacing this completely pacemaker dependent patient).

Summary of Key Facts Relied Upon:

  1. The Patient had an adverse reaction on April 25th, 2011 while the pacemaker was being interrogated.
  2. The pacemaker was again interrogated on May 5, 2011.
  3. The patient died on May 13, 2011.
  4. The pacemaker was not interrogated post mortem by OMI and in fact the first interrogation after the death was done June 8, 2015.
  5. OMI explanted the device and leads and took photos on May 27, 2011 of the Explanted device and leads performed by OMI personnel on that date

The OMI staff and Medtronic personnel both carefully & skillfully explanted both the device and leads in a manner that preserved the structural integrity of both the device and leads except for the fact that the atrial lead had been severed into 3 distinct portion and was

Facts of the case:

This report has been generated on behalf of the A children's heart center for the case involving the alleged incidents related to plaintiff's daughter. This report will focus on the issues related to the technical aspects of both the cardiac pacemaker (EnPulse Model E2DR21P Serial number PMU411109 ) and cardiac pacing leads (Atrial Lead model #496525, SN: LBT042477R-Epicardial Unipolar and Ventricular Lead model #496525, SN: LEN036731R- Bipolar Epicardial) which had been implanted and used by patient until her death. The patient had been completely pacemaker dependent in the DDD mode from the time the device had been implanted on 2006 through the child's passing in 2011.

There had been appropriate testing on the device through regularly scheduled cardiac pacemaker interrogations at the children's heart center which had been supervised by Medtronic personnel, but there had been no interrogatory sessions conducted immediately after the death of plaintiff's daughter and at any time during the immediate period subsequent to the child's death on May 13, 2011. If testing had been conducted on May 13th, it would have provided critical information that the children's heart center had provided an adequate and safe level of DDD pacing.

This report incorporates the complete pacemaker summaries for the dates of April 25th and May 5th; OMI related explanation materials for May 27, 2011; June 8, 2015 testing on both the leads and device testing of the pacemaker/leads. The June 8, 2015 testing was conducted in the presence of all experts (Dr. Yanulis and plaintiff's Expert) and all attorneys involved in this case including (plaintiff's attorneys; and Medtronic's attorneys). The testing protocols had been approved by all parties to the testing conducted at Medtronic's Testing Facility (Minneapolis, MN) on June 8th, 2015, with some slight agreed to testing modifications. Both the explanted pacing device and pacing leads, which had been removed by OMI personnel, had been carefully stored and placed in a secured facility after being sterilized and packaged.

Both the device and leads had some fibrotic tissue attached to both. The device and leads both appeared to be in excellent condition particularly since the device had been stored for over four (4) years at the OMI facility. The device testing/analysis and lead testing/analysis had been performed and the results will be discussed in a later section of this report. Although the Atrial Lead (model #496525, SN: LBT042477R-Epicardial Unipolar lead) had been securely stored it was in three (3) different segments due to this lead as well as the ventricular lead and pacing device being stored in formaldehyde for over a 4-year period. One small portion of the unipolar atrial lead was missing and presumed lost during the autopsy. Medtronic personnel were still able to conduct the macro and microscopic testing analysis as predetermined and agreed upon by all parties prior to the actual testing conducted on June 8th.

It should also be noted that the EnPulse pacemaker device was placed in the custodial care of OMI personnel immediately after patient's death. A battery replacement at the appropriated time based on Medtronic specifications had not been performed. The device as well as the pacing leads were explanted on May 27, 2015. The battery which had not been replaced in over 4 years, lost power and this resulted in valuable diagnostic device information not being available to all parties which would have been relevant and helpful to this case.

My Analysis:

Testing and Analysis conducted at Medtronic Testing Facility:

Device Testing (June, 2015) conducted at Medtronic Testing Facility:

The pacing device had been tested under simulated conditions using both the explanted device and a Medtronic Kappa 8000 cardiac pacemaker (electrically connected to the EnPulse device) since the explanted device had long been without the required battery replacement as called forth in the Medtronic specs for the pacing device used in the plaintiff's daughter. The results obtained support the expert's view that the EnPulse pacing device within the device testing conditions and constraints (from June, 2015 testing conducted at the Medtronic Testing facility) did appropriately pace the patient.

The Explanted EnPulse pacing device which had been electrically connected to the Kappa 8000 pacing device for testing performed in June, 2015 under simulated test conditions and constraints. The pacing device reverted to the VVI mode and paced at 65 ppm (which results when the device battery has reached its Elective Replacement Indicator (ERI)). The "dump device testing" results obtained on this date was reviewed and analyzed by this expert.

My Conclusions:

Within the bounds of reasonable engineering and scientific certainty, and subject to change should additional information become available, it is my professional opinion that:

  • Based on the information contained in this report, that the device had been adequately programmed and was reliably pacing patient's heart.
  • No timely post mortem interrogation had been conducted and the depletion of the battery only allows for the storage of six weeks of diagnostic data to be stored. Once ERI is hit, diagnostic data collection is suspended. This expert estimates that ERI occurred with patient's pacemaker approximately 5 months after patient's death.
  • Additionally, other than some evidence of fibrotic tissue which had adhered to both the unipolar atrial and bipolar ventricular leads, there had been no visible signs of lead fracture, no structural integrity issues (which could be found) from both from the macroscopic and microscopic views which would have adversely affected the overall proper functioning of both said pacing leads as shown in both the OMI device/leads and photos taken during the Device and Lead testing and results obtained from Medtronic Testing conducted by Medtronic personnel (June, 2015, Minneapolis, MN.
  • Since it was now being paced in the VVI mode -which was not the DDD mode which had been used for the patient since the device has long surpassed the ERI. In my opinion, the June, 2015 testing gives no reliable information pertaining to the pacemaker functioning while it was in the patient.
  • If a post-mortem testing session had been conducted, this would have confirmed that the device was working appropriately for patient's pacing needs and a complete summary of the pacing parameters would have been obtained which would have demonstrated that the device had been reliably programmed. In addition, there would have been device diagnostics showing the clinical status of patient's heart from the programmed pacing parameters on the day of her death.

The expert may be willing to change his opinions if additional information is obtained. But based on the information which has been provided and the analysis of all testing conducted, Medtronic specs for both the device and leads used in patient that she had been properly paced by the children's heart center personnel. The pacemaker interrogation sessions should have been conducted immediately following her death and the fact that the device had been stored in formaldehyde for such a long period of time and the resulting battery depletion; reliable and valuable diagnostic information was lost due to the four-year delay in testing. This expert concludes that within a reasonable degree of certainty based on all the information available that the Enpulse device had been appropriated programmed by health facility personnel and that it provided an adequate degree and level of pacing for the patient based on her pacemaker dependency needs.

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George Yanulis, MEng, MS, DEng, is a nationally recognized Cardiovascular Device Product Development and Research Engineer and has conducted cardiovascular device research at the Cleveland Clinic Foundation. He has published in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices. Dr. Yanulis has a Doctorate in Engineering in a joint program between Cleveland State University and the Cleveland Clinic Foundation in Biomedical Engineering; a Master of Science from the University of Pittsburgh; and a Master of Engineering in Biomedical Engineering from the University of Virginia.

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