BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PACEMAKER PULSE-GENERATOR

    MDR report key: 15898216 · Received December 1, 2022

    Report

    Report Number
    2124215-2022-50319
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 18, 2022
    Report Date
    January 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. CORRECTION TO FIELD D2A: COMMON DEVICE NAME AND D2B: PRO CODE (PRODUCT CODE).

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574787 IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY BOSTON SCIENTIFIC CORPORATION
    478808 IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown