BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951016 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23484
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE APPOINTMENT, THE SHOCK IMPEDANCE MEASUREMENT WAS 46 OHMS. ALL OTHER MEASUREMENTS WERE ACCEPTABLE. A REVISION PROCEDURE WAS PERFORMED, AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. 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, DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS NOTED THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD SEVERAL DAILY IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. WHEN PATIENT MANEUVERS WERE PERFORMED, NOISE WAS OBSERVED ON THE SHOCK CHANNEL. 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 Required Intervention