BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211258 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08206
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    January 30, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RECEIVED IN TWO SEGMENTS, SEVERED 20 CM FROM THE IS-1 TERMINAL PIN. A PORTION OF THE OUTER INSULATION WAS MISSING, AND AN EXTRACTING STYLET WAS STUCK IN THE DISTAL SEGMENT. ELECTRICAL TESTING WAS PERFORMED ON THE LEAD SEGMENTS; ALL PATHWAYS EXCEPT WHERE THE STYLET WAS STUCK PASSED THE CONTINUITY TESTS. AN X-RAY EXAMINATION OF THE DISTAL SEGMENT REVEALED NO FRACTURE IN THE CONDUCTOR COILS. VISUAL INSPECTION CONFIRMED SURFACE ABRASION AND TORN INSULATION APPROXIMATELY 19 CM FROM THE IS-1 TERMINAL PIN. THAT DAMAGE IS CONSISTENT WITH LOCALIZED COMPRESSIVE STRESS ON THE SURFACE OF THE OUTER INSULATION, LIKELY DUE TO ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION. THE REPORTED INCREASE IN PACING IMPEDANCE MEASUREMENTS IS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE LEAD WAS DAMAGED DURING REMOVAL. THE EXPLANTED LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE LEAD WAS DAMAGED DURING REMOVAL. THE EXPLANTED LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO AN INCREASE IN PACING IMPEDANCE MEASUREMENTS. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309966 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 0181| MISMATCH| 4471