BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153597 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06235
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS REMAIN IN SERVICE. 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

    IT WAS LATER REPORTED THAT THIS PATIENT RECEIVED A NEW NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD WHICH DID NOT SENSE VENTRICULAR FIBRILLATION DURING THRESHOLD TESTING. THE RATE SENSE PORTION OF THIS NON-BOSTON LEAD WAS CAPPED AND THE 0157 WAS REINSTATED. THE PATIENT WAS UPGRADED TO A NON-BOSTON SCIENTIFIC DEVICE. THE FIELD REPRESENTATIVE REPORTED THEY WOULD TRY TO LOCATE THE EXPLANTED DEVICE AND RETURN IT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR LEAD HAD OVERSENSED ATRIAL FLUTTER/ATRIAL FIBRILLATION EVENTS. THIS RESULTED IN PACING INHIBITION THAT LASTED MORE THAN THREE SECONDS IN A DEVICE DEPENDENT PATIENT. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. 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 93 YR 4285| 1294| H179| H177| 4517| 4469| 1230| 0157| 0158| 4269| 4088