BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 7433740 · Received April 16, 2018

    Report

    Report Number
    2124215-2018-06806
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    March 22, 2018
    Report Date
    March 22, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER 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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED. IT WAS CONFIRMED VIA X-RAY AND LOSS OF CAPTURE. THE CAUSE COULD BE ATTRIBUTED TO THE PATIENT'S EXERCISE MOTION. THE LV LEAD EXHIBITED LOSS OF CAPTURE AND THE SLACK COULD NOT BE ADVANCED. THE LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275013 ACUITY IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4672

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R 4671| 4672| 7742| G148| MISMATCH