BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871190 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17792
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT BOTH MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) RATE/SENSE LEAD PORTION OF THE DEVICE SYSTEM, DID OVERSENSE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) ACTIVITY WHICH RESULTED IN 2.2 SECONDS OF PAUSE IN PACING FOR THE PACEMAKER DEPENDANT PATIENT. THE PATIENT WAS ASYMPTOMATIC. THE NOISE DID NOT APPEAR TO BE EXTERNAL TO THE SYSTEM AND WAS NOT REPRODUCIBLE. ELECTRICAL RE-PROGRAMMING WAS DONE TO MITIGATE THE ISSUE, AND THE FOLLOWING PHYSICIAN PLANNED TO FOLLOW UP WITH THE PATIENT IN THE NEAR FUTURE.

    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 79 YR H177| 0185| 4549