BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053227 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03966
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. EVENT CLARIFICATION AND RESOLUTION WAS REQUESTED. IT WAS LATER REPORTED THAT THIS VENTRICULAR LEAD HAD DISLODGED WHICH RESULTED IN THE PREVIOUS ALLEGATIONS. THE LEAD WAS SUCCESSFULLY REPOSITIONED WITHOUT ISSUE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION NOTES THE RIGHT VENTRICULAR THRESHOLDS HAVE RISEN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OVERSENSED WHICH RESULTED IN AN UNNECESSARY SHOCK TO THIS PATIENT. THERE WAS DISCUSSION WITH TECHNICAL SERVICES OF POSSIBLE CAUSES. IT WAS LATER DISCOVERED THAT THIS DEVICE HAD BEEN PROGRAMMED TO OTHER THAN MONITOR + THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention E110| 0157| 4470