BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 11233752 · Received January 26, 2021

    Report

    Report Number
    2124215-2021-02271
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    October 13, 2020
    Report Date
    June 24, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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, 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 · 0

    IT WAS REPORTED THAT THIS PATIENT PRESENTED WITH INCREASING SHORTNESS OF BREATH SINCE IMPLANT IN OCTOBER. THE PHYSICIAN SUSPECTED PACEMAKER INDUCTED CARDIOMYOPATHY. THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED FROM THE APEX. A NEW LEAD WAS SUCCESSFULLY PLACED IN THE BUNDLE OF HIS TO OPTIMIZE CARDIAC FUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT PRESENTED WITH INCREASING SHORTNESS OF BREATH SINCE IMPLANT IN OCTOBER. THE PHYSICIAN SUSPECTED PACEMAKER INDUCTED CARDIOMYOPATHY. THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED FROM THE APEX. A NEW LEAD WAS SUCCESSFULLY PLACED IN THE BUNDLE OF HIS TO OPTIMIZE CARDIAC FUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130525 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1015898 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R