BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053387 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04424
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT, THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE H170 WAS RETURNED TO THE PATIENT AND THE N119 REMAINS IMPLANTED. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D/H170) DETECTED SHOCK IMPEDANCES GREATER THAN 90 OHMS WHILE IMPLANTED WITH THIS CHRONIC RIGHT VENTRICULAR LEAD. THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. HOWEVER, DURING THE IMPLANT PROCEDURE GREATER THAN 125 OHMS WAS DETECTED ON THE CHRONIC DEFIBRILLATION LEAD AND NEW CRT-D (N119). 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 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 4542| H170| MISMATCH| 0184| N119