BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY PLUS

    MDR report key: 12644284 · Received October 17, 2021

    Report

    Report Number
    2124215-2021-30287
    Event Type
    Injury
    Date Received
    October 17, 2021
    Date of Event
    September 5, 2021
    Report Date
    December 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604522
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 INTEGRITY. MEASUREMENTS WERE WITHIN NORMAL LIMITS. NOTED CUTS IN THE OUTER INSULATION, LIKELY EXPLANT DAMAGE. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN IRIS PER THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HEART WALL PERFORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN IRIS PER THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HEART WALL PERFORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542238 INGEVITY PLUS IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1009902 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Life Threatening| H| R