BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 14528488 · Received May 27, 2022

    Report

    Report Number
    2124215-2022-16771
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 17, 2023
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND NO ANOMALIES. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THIS TEST WERE WITHIN NORMAL LIMITS. 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS DUE TO A SUSPECTED MICRO DISLODGMENT OR A DEFECTIVE LEAD. THIS WAS NOT COMPLETELY CONFIRMED WHEN X-RAYS AND FLUOROSCOPIC EVALUATION WERE PERFORMED. THE LEAD WAS INTENDED TO BE REPOSITIONED BUT NO ACCEPTABLE MEASUREMENTS WERE OBTAINED. THEREFORE, IT WAS REPLACED WITH A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS DUE TO A SUSPECTED MICRO DISLODGMENT OR A DEFECTIVE LEAD. THIS WAS NOT COMPLETELY CONFIRMED WHEN X-RAYS AND FLUOROSCOPIC EVALUATION WERE PERFORMED. THE LEAD WAS INTENDED TO BE REPOSITIONED BUT NO ACCEPTABLE MEASUREMENTS WERE OBTAINED. THEREFORE, IT WAS REPLACED WITH A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674885 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1014714 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R