BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY PLUS

    MDR report key: 12112466 · Received July 2, 2021

    Report

    Report Number
    2124215-2021-14253
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    April 10, 2021
    Report Date
    August 5, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND SHOWED A DECREASE IN AMPLITUDE AND AN INCREASE IN PACING THRESHOLDS WITH A YELLOW ALERT. THE DISLODGEMENT WAS CONFIRMED BY X-RAY. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND SHOWED A DECREASE IN AMPLITUDE AND AN INCREASE IN PACING THRESHOLDS WITH A YELLOW ALERT. THE DISLODGEMENT WAS CONFIRMED BY X-RAY. THE LEAD IS SCHEDULED TO BE REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003881 INGEVITY PLUS IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1010670 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R