BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 15432330 · Received September 15, 2022

    Report

    Report Number
    2124215-2022-36270
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 26, 2022
    Report Date
    November 3, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604577
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED LEAD WAS ANALYZED. VISUAL INSPECTION OF THE LEAD NOTED BOTH THE INTERNAL AND THE EXTERNAL INSULATION WAS ABRADED THROUGH TO THE CONDUCTOR COIL. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO DISLODGEMENT AND INCREASED LOWER RATE LIMIT (LRL). PATIENT WAS PROGRAMMED TO A LOWER LRL PER PHYSICIAN, INCIDENTALLY RESULTING IN A PERIOD OF REDUCED HEART RATE BELOW DESIRED THERAPY CAUSING DISCOMFORT AND FATIGUE. DISLODGEMENT WAS CONFIRMED VIA FLUOROSCOPY. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO DISLODGEMENT AND INCREASED LOWER RATE LIMIT (LRL). PATIENT WAS PROGRAMMED TO A LOWER LRL PER PHYSICIAN, INCIDENTALLY RESULTING IN A PERIOD OF REDUCED HEART RATE BELOW DESIRED THERAPY CAUSING DISCOMFORT AND FATIGUE. DISLODGEMENT WAS CONFIRMED VIA FLUOROSCOPY. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126129 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1023934 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| H