BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2914358 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00649
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE DEVICE WAS RECENTLY IMPLANTED. THE PATIENT WILL BE CHECKED ON MONDAY WITH DEFIBRILLATION THRESHOLD (DFT) TESTING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BROUGHT IN FOR ANTI-TACHYCARDIA PACING (ATP) TESTING. THE PATIENT ALSO UNDERWENT DEFIBRILLATION THRESHOLD (DFT) TESTING AND THE IMPEDANCES WHERE WITHIN NORMAL LIMITS. THERE WERE NO CHANGE MADE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19721 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 0184| T175| E141