BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211147 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08385
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED, THE LEAD WAS SURGICALLY ABANDONED AND A NEW IMPLANTABLE DEFIBRILLATION LEAD WAS IMPLANTED. THE LEAD IS NOT EXPECTED TO BE RETURNED AT THIS TIME. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD PRESENTED TO THE HOSPITAL FOLLOWING RECEIPT OF THREE SHOCKS. INTERROGATION OF THE DEVICE REVEALED A SHORT CIRCUIT CONDITION DETECTED DURING SHOCK DELIVERY AND A CHARGE TIME OUT FAULT MESSAGE. ADDITIONALLY, THE DEVICE WAS IN SAFETY CORE AND A LIMITED DEVICE FUNCTIONALITY MESSAGE WAS OBSERVED. THE THERAPY EPISODES WERE UNABLE TO BE VIEWED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED A POTENTIAL LEAD ISSUE AND DISCUSSED DEVICE AND LEAD REPLACEMENT. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310365 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 1861| E110| T167| 4470| 0148