BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162536 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08338
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACE/SENSE CHANNEL OF THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY CAPPED FOR AN UNKNOWN REASON AND SUCCESSFULLY REPLACED. ADDITIONAL INFORMATION INDICATED THERE WAS NOISE ON THE PACE/SENSE CHANNEL RESULTING IN PACING INHIBITION. IT WAS NOTED THAT DEFIBRILLATION THRESHOLD TESTING WAS PERFORMED TO ENSURE THE SHOCK PORTION OF THE LEAD WAS FUNCTIONING APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 86 YR 0185| N118| 4088| 4087| H175| 4525