BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910903 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16540
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IN THE EMERGENCY ROOM FOR NON-DEVICE RELATED ISSUES WHEN THEY EXPERIENCED A RUN OF VENTRICULAR TACHYCARDIA (VT). CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOCKED THE PATIENT ONE TIME AND THEN WAS UNABLE TO DELIVER ANY FURTHER SHOCKS. SUBSEQUENTLY THE PATIENT RECEIVED TWO TO THREE EXTERNAL SHOCKS. UPON INTERROGATION TWO FAULT CODES WERE OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT ONE FAULT CODE WAS DUE TO A SHORTED LEAD CIRCUIT AND THE OTHER FAULT CODE WAS FOR A CAPACITOR CHARGE TIME THAT HAS EXCEEDED THE CHARGE TIME LIMIT. TS ADVISED THAT THE PATIENT WOULD BE CONSIDERED UNPROTECTED AND BOTH THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD SHOULD BE EXPLANTED. A REVISION PROCEDURE WAS PERFORMED WHERE THE DEVICE WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17478 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R T125| 0184| 4469| 4548| N119