BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3232020 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11209
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT WAS BEING UPGRADED FROM A SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEFT VENTRICULAR (LV) AND RIGHT ATRIAL (RA) LEADS WERE SUCCESSFULLY IMPLANTED. WHEN THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS ATTACHED TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ((B)(4)) THERE WERE INTERMITTENT PAUSES NOTED ON THE MONITOR; STRIPS SHOWED THAT ATRIAL PACED AND ATRIAL SENSED BEATS PERIODICALLY RESULTED IN OVERSENSING AND PACING INHIBITION ON THE RV ELECTROGRAM (EGM). THE PATIENT WAS PACEMAKER DEPENDENT AND PAUSES GREATER THAN TWO SECONDS WERE OCCASIONALLY OBSERVED. CONNECTIONS WERE CHECKED MULTIPLE TIMES, PROGRAMMING PARAMETERS WERE MODIFIED AND THE ISSUE WAS STILL NOTED. A NEW CRT-D ((B)(4)) WAS THEN OPENED, USED, AND YIELDED THE SAME RESULTS. IN VVI MODE THERE WAS NORMAL FUNCTION, HOWEVER, THE PHYSICIAN DID NOT WAS THE DEVICE PROGRAMMED VVI, NOR DID HE WANT TO REVISE THE LEADS. THEREFORE, A COMPETITOR'S DEVICE WAS THEN CONNECTED WITH SIMILAR OBSERVATIONS NOTED, HOWEVER, DUE TO AN AVAILABLE PACING ALGORITHM RV PACING REMAINED AVAILABLE AND WITH A DECREASED RV SENSITIVITY THE OVERSENSING APPEARED RESOLVED. THE COMPETITOR'S GENERATOR REMAINED IN SERVICE WITH THIS CHRONIC RV LEAD AND NEWLY IMPLANTED RA AND LV LEADS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A FEW DAYS POST IMPLANT OF THE COMPETITOR'S DEVICE, THE SAME OBSERVATIONS WERE BEING NOTED AGAIN. THE DEVICE WAS REPROGRAMMED TO DDD MODE WITH A SUB-CAPTURE THRESHOLD AS THE DROPPED BEATS WERE WITH ATRIAL PACING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332607 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4542| E102| 0184| N161