BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211103 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07802
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE SPOKE WITH THE CLINIC. IT WAS DECIDED TO OBSERVE FOR THE MOMENT. NO IN-CLINIC FOLLOW-UP WAS PLANNED AND A REMOTE FOLLOW-UP WAS SCHEDULED IN ONE MONTH TO RE-EVALUATE. IT WAS REPORTED THAT SHOCK IMPEDANCE MEASUREMENTS HAD BEEN BETWEEN 95-117 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 ASSOCIATED RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. AN ALERT WAS ISSUED IN THE PATIENT'S REMOTE MONITORING SYSTEM FOR THIS MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310611 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR 0181| E102