BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA 60

    MDR report key: 24747185 · Received March 31, 2026

    Report

    Report Number
    2124215-2026-17692
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526474453
    PMA / PMN Number
    N970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. AMENDMENT: THIS DEVICE WORKED AS INTENDED. THERE WAS NO MALFUNCTION PRESENT. THE DEVICE WAS AT END OF LIFE (EOL).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED. THE DEVICE DISPLAYED AN ERROR CODE INDICATED OF NON-COMPLETION OF INITIAL INTERROGATION. THE DEVICE HAS BEEN IN SERVICE FOR OVE 15 YEARS, END OF LIFE (EOL) IS SUSPECTED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED. THE DEVICE DISPLAYED AN ERROR CODE INDICATED OF NON-COMPLETION OF INITIAL INTERROGATION. THE DEVICE HAS BEEN IN SERVICE FOR OVE 15 YEARS, END OF LIFE (EOL) IS SUSPECTED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION OBTAINED, THE DEVICE WAS NOT ABLE TO BE INTERROGATED DUE TO BEING IN END OF LIFE (EOL). THE PATIENT RECEIVED A GENERATOR CHANGE WITH A COMPETITOR'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809580 ALTRUA 60 PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION S606 124540 00802526474453

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male