BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREEPI

    MDR report key: 3921922 · Received July 9, 2014

    Report

    Report Number
    2649622-2014-07634
    Event Type
    Death
    Date Received
    July 9, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY THREE WEEKS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE SYSTEM. THE PATIENT IS REPORTED TO HAVE PASSED AWAY AT HOME. PHYSICIAN REVIEW OF THE RECORDED EPISODES DID NOT SHOW ANY FAILURE TO TREAT HOWEVER THREE EPISODES WERE OVERWRITTEN BUT SUBSEQUENT EPISODES. THE INITIAL EPISODE REVIEWED WITH ELECTROGRAM NOTED THE PATIENT HAD NON-SUSTAINED VENTRICULAR FIBRILLATION (VF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401281 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death DTBC2D4 ICD, 6935M-62 LEAD