BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170396 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10692
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    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

    THE PHYSICAIN DID MODIFY DEVICE PROGRAMMING, BY EXTENDING DURATION TO TEN SECONDS. THIS DEVICE REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT SHORT. INTERMITTENT NOISE OVERSENSING THAT LED TO ONE INSTANCE OF GREATER THAN 2 SECONDS OF ASYSTOLE FOR THE PATIENT. THE PATIENT HAD ALREADY BEEN IN THE HOSPITAL FOR A NON-HEART RELATED SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention N119| MISMATCH| 0185| B301