BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3905807 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-13166
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED IN TWO SEGMENTS, SEVERED 550 MILLIMETERS (MM) FROM THE TERMINAL PIN. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP NOTED FLATTENED CONDUCTOR COILS AND PUNCTURE HOLES IN THE INSULATION. THE DAMAGE TO THE LEAD WAS CONSISTENT WITH DAMAGE CAUSED BY THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED ONE DAY POST IMPLANT DUE TO A PRODUCT PERFORMANCE ISSUE. ATTEMPTS TO OBTAIN ADDITIONAL WERE MADE, HOWEVER NO FURTHER INFORMATION WAS RECEIVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382513 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4592| 4555| N160| 0293