BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162602 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07072
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD UNDERGONE KNEE SURGERY. FOLLOWING THE KNEE SURGERY, THE SYSTEM WAS CONFIRMED TO BE FUNCTIONING APPROPRIATELY. TWO DAYS LATER, THE PATIENT RECEIVED TWO SHOCKS. THAT NIGHT, THE PATIENT PERFORMED A LATITUDE INTERROGATION. AFTER THE INTERROGATION, THE PHYSICIAN CALLED STATING THERE WAS A LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR N119| 0185| 4054| T125