BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161635 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07707
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE THEN REPORTED THAT THE PATIENT HAD BEEN SENT HOME WITH A LIFE VEST AND THAT THE DEVICE HAD BEEN DEACTIVATED. TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IMPLANTED. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD RECENTLY IMPLANTED IN ASSOCIATION WITH THE CHRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID APPEAR TO EXHIBIT HIGH RV PACE IMPEDANCE PER THE LATITUDE RED ALERT THAT WAS GENERATED. THE PRIOR NON-BSC RV LEAD HAD BEEN REMOVED FROM SERVICE FOR REASON OF FRACTURE.

    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 70 YR 4470| 6949| T127| 0185