BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951052 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-11257
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    September 30, 2013
    Report Date
    November 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE LEAD WAS SEVERED 81 AND 249 MILLIMETERS (MM) FROM THE TERMINAL PIN. A TOTAL OF THREE SEGMENTS WERE RETURNED. VISUAL ANALYSIS REVEALED INSULATION DAMAGE THAT WENT THROUGH ALL FOUR LAYERS OF THE INSULATION, THROUGH TO THE RATE/SENSE CONDUCTOR COIL 60-67 MILLIMETERS FROM THE TERMINAL PIN. THE ABRADED REGION OF THE LEAD WOULD HAVE BEEN LOCATED WITHIN THE POCKET AREA. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT WAS LIKELY CAUSED BY LEAD-ON-CAN CONTACT COUPLED WITH MOVEMENT AND PRESSURE. SURFACE ABRASIONS WERE NOTED ON THE TERMINAL BOOT AREA AS WELL; ONE WAS IN LINE WITH THE ABRASION (CONTINUING LEAD-ON-CAN) AND ONE WAS ADJACENT TO THE ABRASION (MOST LIKELY LEAD-ON-LEAD). LABORATORY ANALYSIS CONFIRMED THE FIELD ALLEGATION AND THAT PACING THERAPY WOULD HAVE BEEN COMPROMISED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED WHICH RESULTED TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THIS RV LEAD WAS EXPLANTED AND WAS SUCCESSFULLY REPLACED. DURING THE REVISION PROCEDURE, A LEAD INSULATION ISSUE WAS SEEN AND THE PHYSICIAN BELIEVED IT WAS DUE TO LEAD-TO-CAN ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427913 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 MISMATCH| 0693| 0296| 4096| 4555| P142| 4543