BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210080 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06777
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 22, 2012
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE MONITORING. 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 EXHIBITED CHRONIC HIGH THRESHOLD MEASUREMENTS AND NOISE ON THE RATE/SENSE CHANNEL RESULTING IN ONE DIVERTED SHOCK. A LEAD FRACTURE OR SUBCLAVIAN CRUSH WAS SUSPECTED. A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT IS AT HIGH RISK FOR ANY FURTHER INTERVENTION, SO PROGRAMMING CHANGES WERE MADE TO PREVENT UNNECESSARY SHOCK THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312027 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 4469| 0157| E110