BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161607 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07235
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 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

    AS A RESULT IT WAS INITIALLY REPORTED THAT THE PHYSICIAN EXPLANTED THE DEVICE AND SURGICALLY ABANDONED BOTH LEADS. HOWEVER, A REPRESENTATIVE LATER PROVIDED THAT THE PHYSICIAN HAD LEFT THE DEVICE IMPLANTED. THE PHYSICIAN WAS ORIGINALLY CONCERNED IF THE DEVICE HEADER WAS INVOLVED. HOWEVER, THERE WERE NO VISUAL PROBLEMS WITH HEADER AND DEVICE FUNCTION WAS NORMAL AT END OF CASE AND AT THE NEXT DAY CHECK WITH THE NEWLY IMPLANTED LEADS. INVESTIGATION IS COMPLETE TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE BROKEN. THE CRT-D DETECTED NOISE ON BOTH THE NON-BOSTON ATRIAL LEAD AND THE RATE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD. THIS NOISE WAS OVERSENSED WHICH RESULTED IN UNNECESSARY ANTI-TACHYCARDIA PACING AND SHOCKS. THE PATIENT WAS NOT DEPENDANT AND THERE WAS NO ASYSTOLE REPORTED. THIS WAS A SUB-MUSCULAR IMPLANT. IN ADDITION, THE IMPEDANCE ON THE NON-BOSTON ATRIAL LEAD MEASURED FROM 614 TO <200 OHMS. THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS STABLE IN THE 400 OHMS RANGE UNTIL RECENTLY WENT UP TO 1010 OHMS. 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 90 YR Required Intervention H175| 4088| 0157| H155| 4087| N119| 4592| 4517| 1488T