BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 11356324 · Received February 20, 2021

    Report

    Report Number
    2124215-2021-03785
    Event Type
    Injury
    Date Received
    February 20, 2021
    Date of Event
    January 25, 2021
    Report Date
    June 24, 2021
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS, SHOULD PERTINENT INFORMATION BE PROVIDED. 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. CUTS IN THE OUTER INSULATION WERE NOTED APPROXIMATELY 15 CM FROM THE TERMINAL END, LIKELY EXPLANT DAMAGE. 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 OF HIGH CAPTURE THRESHOLDS AND DISLODGEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND MICRO-DISLODGED. THE MICRO-DISLODGEMENT WAS SUSPECTED AS THE LEAD EXHIBITED HIGH PACING THRESHOLDS, AND THE X-RAY DID NOT SHOW A NOTICEABLE CHANGE IN THE LEAD'S POSITION. SUBSEQUENTLY, THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS, SHOULD PERTINENT INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND MICRO-DISLODGED. THE MICRO-DISLODGEMENT WAS SUSPECTED AS THE LEAD EXHIBITED HIGH PACING THRESHOLDS, AND THE X-RAY DID NOT SHOW A NOTICEABLE CHANGE IN THE LEAD'S POSITION. SUBSEQUENTLY, THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253245 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1041611 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R