BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3093175 · Received May 4, 2013

    Report

    Report Number
    2124215-2013-07408
    Event Type
    Injury
    Date Received
    May 4, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. MEASUREMENTS WERE OUT OF RANGE IN ALL CONFIGURATIONS. COMMANDED SHOCKS WERE DELIVERED WHICH YIELDED ACCEPTABLE MEASUREMENTS. A SAVE TO DISK WAS PERFORMED AND NO DEVICE ANOMALIES WERE NOTED. THE DEVICE EMITTED BEEPING TONES AT A LATER DATE DUE TO HIGH OUT OF RANGE MEASUREMENTS AGAIN BEING DETECTED. AN INVASIVE PROCEDURE WAS PERFORMED. ALL CONNECTIONS WERE SECURE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195777 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R E110| 4470| 0185