BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950655 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24408
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    March 1, 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

    MOST RECENTLY, THIS RV LEAD WAS REMOVED FROM SERVICE DUE TO AN INCREASE IN PACE THRESHOLDS DURING A NORMAL DEVICE CHANGEOUT. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT BEYOND ELECTRICAL RE-PROGRAMMING TO LEAST, BOTH MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT MYOPOTENTIAL OVERSENSING WITH SUBSEQUENT PACEMAKER INHIBITION OF GREATER THAN 2 SECONDS AT ONE TIME. THE NOISE OVERSENSING ISSUE COULD NOT BE REPRODUCED WITH ISOMETRICS. HOWEVER, THE MEDICAL CARE PERSONNEL DID RE-PROGRAM THE DEVICE TO LEAST SETTING IN ORDER TO MITIGATE SINCE THE PATIENT IS PACEMAKER DEPENDENT. IT WAS NOTED BY THE LOCAL AREA SALES REPRESENTATIVE THAT THE MYOPOTENTIAL OVERSENSING DID OCCUR AT AN AIRPORT AND THAN ELECTROMAGNETIC INTERFERENCE (EMI) MAY HAVE BEEN A CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4087| T125| 0158