BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 4132202 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17518
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE IN ALL CONFIGURATIONS SHORTLY AFTER IMPLANT. THE LEAD WAS SUSPECTED TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT REPORTED HAVING FLUID IN THEIR LUNGS AND HEART, OF WHICH, THE PATIENT'S PHYSICIAN WAS AWARE. THE LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612081 ACUITY IMPLANTABLE HF LEADS LWP CPI - DEL CARIBE 4593

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R V173| 4088| 4047| 1297| S602| 4137| 4593| 5076