BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4903654 · Received July 9, 2015

    Report

    Report Number
    2124215-2015-08764
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 14, 2015
    Report Date
    June 16, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    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) DETECTED LOW OUT-OF-RANGE SHOCK IMPEDANCES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED BRINGING THE PATIENT IN FOR TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446810 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0149

    Patients

    Seq Age Sex Outcome Treatment
    1 0015| F110| 0149| 1871