BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATCH

    MDR report key: 1042557 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34092
    Event Type
    Death
    Date Received
    May 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    September 6, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY FOUND THAT THE LAST MANUAL IMPEDANCES MEASUREMENTS WERE PERFORMED SEVEN DAYS PRIOR TO THE PATIENT'S REPORTED DEATH. THE SHOCK IMPEDANCE WAS <20, >125 OHMS AND THE RIGHT VENTRICULAR (RV) IMPEDANCE WAS 698 OHMS. THE LAST RIGHT ATRIAL (RA) MANUAL IMPEDANCE WAS MADE IN LATE (B)(6) 2008 AND WAS GREATER THAN 3000 OHMS. RA IMPEDANCE TESTING WAS PERFORMED AND WAS FOUND WITHIN NORMAL RANGE. PACING, SENSING, AND SHOCKING FUNCTIONS WERE VERIFIED PER LABORATORY TESTING. THE RECORDED PACING AND SHOCK IMPEDANCE FOLLOWING LABORATORY TESTING WERE WITHIN NORMAL RANGE. IT WAS CONCLUDED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING. TECHNICAL SERVICES (TS) REVIEWED A SAVE-TO-DISK AND EVALUATED AN EPISODE THAT HAD BEEN RECORDED ONE DAY PRIOR TO THE REPORTED DEATH. ELECTROGRAMS WERE NOT AVAILABLE FOR REVIEW, HOWEVER, A REVIEW OF THE INTERVALS IDENTIFIED WHAT IS LIKELY VENTRICULAR TACHYCARDIA (VT) THAT APPEARS TO HAVE BEEN SUCCESSFULLY TERMINATED WITH ONE BURST OF ATP. THE RECORDED VT CYCLE LENGTH WAS IN THE RANGE OF 390-400 MS. FOLLOWING ATP DELIVERY, THE RATE FALLS BACK TO THE LOWER RATE LIMIT (LRL) WITH RATE-SMOOTHING. ALL OF THE SUBSEQUENT EPISODES APPEAR TO HAVE OCCURRED AFTER THE PATIENT DEATH AND LIKELY THE DEVICE WAS STILL ACTIVE AND HAD NOT BEEN PROGRAMMED OFF AT THAT TIME. TS CONCLUDED THAT THE DEVICE APPEARS TO HAVE BEEN FUNCTIONING NORMALLY BASED ON THE DATA CONTAINED ON SAVE-TO-DISK. THE EPICARDIAL PATCHES WERE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2008 THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD RIGHT VENTRICULAR (RV) SHOCKING LEAD IMPEDANCE (SLI) MESSAGE FROM THE EPICARDIAL LEADS OF "LESS THAN 20, GREATER THAN 125 OHMS". A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT A HIGH-ENERGY TEST SHOULD BE PERFORMED TO VERIFY LEAD INTEGRITY. AT THAT TIME, THE AVAILABLE INFORMATION SUGGESTED THAT THIS DEVICE REMAINED IN SERVICE WITHOUT ADDITIONAL COMPLICATION. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT IN (B)(6) 2011 AND THAT THE PATIENT HAD DIED ONE WEEK FOLLOWING THE INITIAL CALL TO TECHNICAL SERVICES IN (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATCH IMPLANTABLE LEAD NHW HISTORICAL PUERTO RICO 0041 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| O THE DEVICE 0010/(B)(4) WAS IMPLANTED (B)(6) 1994| THE DEVICE 0014/(B)(4) WAS IMPLANTED (B)(6) 1998| THE DEVICE 1858/(B)(4) WAS IMPLANTED (B)(6) 2006| THE DEVICE 0041/(B)(4) WAS IMPLANTED (B)(6) 1992| THE DEVICE 0014/200671 WAS IMPLANTED 03-FEB-1998| THE DEVICE 0041/211326 WAS IMPLANTED 08-JUL-1992| THE DEVICE 1858/801127 WAS IMPLANTED 14-NOV-2006| THE DEVICE 0010/007545 WAS IMPLANTED 11-JUL-1994