BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050075 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05132
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED. 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 THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE HAD EMITTED BEEPING TONES WHICH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED COULD OCCUR DUE TO HIGH OUT OF RANGE MEASUREMENTS BEING DETECTED. ALL OTHER LEAD DIAGNOSTICS WERE ACCEPTABLE AND STABLE. THERE WAS NO EVIDENCE OF NOISE OR INAPPROPRIATE THERAPY. AN INVASIVE PROCEDURE WAS PERFORMED AND THESE PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149574 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R T180| 4470| 0181