BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905402 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10755
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THE TRILUMEN INSULATION HAD ABRASION THROUGH TO AND EXPOSED THE RATE SENSING COILS APPROXIMATELY 27 CM TO 28.5 CM FROM THE IS-1 TERMINAL PIN. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF LEAD CONTACT WITH ANOTHER LEAD. THE REPORTED OVERSENSING IS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING THAT WAS NOT REPRODUCIBLE WITH ISOMETRICS. MUSCLE STIMULATION WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND A NEW LEAD IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383040 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR N161| 4195| 0181| E110| 4135| 0185