BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051965 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03940
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 27, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST QUALITY ASSURANCE LABORATORY IT WAS NOT POSSIBLE TO CONFIRM OVERSENSING AND A DECREASE IN PACING IMPEDANCES. HOWEVER, IT WAS CONFIRMED THAT TWO PILLARS OF THE RATE SENSE (RS) CONDUCTOR COILS ARE FRACTURE, POSSIBLY RESULTING IN OVERSENSING REPORTED. DETAILED ANALYSIS WILL BE CONDUCTED, UPON COMPLETION THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS REVEALED A LONG SURFACE ABRASION ON THE LEADS INSULATION, THIS TYPE OF ABRASION WAS MOST LIKELY CAUSED BY LEAD ON LEAD INTERACTION WITHIN THE DEVICE POCKET AREA, AS WELL AS COMPRESSIVE MOVEMENT. IN ADDITION TWO CONDUCTOR WIRES OF THE RATE/SENSE (RS-COIL) WERE FRACTURED. THE FRACTURE SURFACES OF THE TWO WIRES SHOWED SOME EVIDENCE OF FATIGUE. LABORATORY ANALYSIS COULD NOT CONFIRM OVERSENSING AND DECREASED IN PACING IMPEDANCES, HOWEVER THE OBSERVED MALFUNCTION COULD HAVE RESULTED IN THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OVERSENSING AND A DECREASED IN PACING IMPEDANCES WAS NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD. THIS LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS. 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 0185

    Patients

    Seq Age Sex Outcome Treatment
    1