BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 17261618 · Received July 5, 2023

    Report

    Report Number
    2124215-2023-35141
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. THE TIMEFRAME IN WHICH THE ESTIMATED LONGEVITY CHANGE WAS OBSERVED HAS NOT BEEN SPECIFIED. THERE IS NO EVIDENCE TO SUGGEST A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. THE DEVICE REMAINS IN SERVICE AND THERE IS NO EVIDENCE TO SUGGEST A DEVICE REPLACEMENT PROCEDURE HAS BEEN SCHEDULED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT DID NOT ATTEND THE SCHEDULED REPLACEMENT PROCEDURE, THEREFORE, THE DEVICE STILL REMAINS IN SERVICE AND HAS NOT YET BEEN RE-SCHEDULED FOR REPLACEMENT. NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. THE TIMEFRAME IN WHICH THE ESTIMATED LONGEVITY CHANGE WAS OBSERVED HAS NOT BEEN SPECIFIED. THERE IS NO EVIDENCE TO SUGGEST A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. THE DEVICE REMAINS IN SERVICE AND THERE IS NO EVIDENCE TO SUGGEST A DEVICE REPLACEMENT PROCEDURE HAS BEEN SCHEDULED AT THIS TIME. NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786354 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 295454

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Unknown