BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 17240107 · Received June 30, 2023

    Report

    Report Number
    2124215-2023-34299
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523304
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY FOUND NO ANOMALIES. DEFORMED COILS WERE NOTED AT APPROXIMATELY 180, 195, 365, AND 390 MM FROM THE TERMINAL END. CUTS WERE ALSO NOTED ON THE OUTER INSULATION AND INTERPRETED AS NORMAL SURGERY RELATED DAMAGE. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DAY POST IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD APPEARED TO HAVE DISLODGED. A LEAD REVISION WAS PERFORMED, THE RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED AND ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DAY POST IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD APPEARED TO HAVE DISLODGED. A LEAD REVISION WAS PERFORMED, THE RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD IS EXPECTED TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22177 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7731 1078656 00802526523304

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R