BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA 60

    MDR report key: 17488828 · Received August 9, 2023

    Report

    Report Number
    MW5121527
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    February 16, 2022
    Report Date
    December 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWP
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT THEIR IPG WAS HIT AT 45 MPH ON (B)(6) 2014. PT. REPORTED HAVING PROBLEMS WITH THEIR IPG SINCE THAT DATE AND "FINALLY IT SNAPPED AS I CALL IT ON (B)(6) 2021". THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2022. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905211 ALTRUA 60 IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC S606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown