BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVE?

    MDR report key: 21942351 · Received May 1, 2025

    Report

    Report Number
    2124215-2025-27887
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526536632
    PMA / PMN Number
    P030005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ENTERED SAFETY MODE. THIS CRT-P WAS EXPLANTED AND REPLACED WITH A NEW CRT-P. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191152 INVIVE? PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION V173 106538 00802526536632

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Required Intervention| H