BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 9549714 · Received January 6, 2020

    Report

    Report Number
    2124215-2019-27225
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    October 29, 2019
    Report Date
    January 4, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE FURTHER UPDATED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE WAS EXHIBITING ACCELERATED BATTERY DEPLETION, BASED ON DATE OF IMPLANT. TO DATE, NO DEVICE HISTORY NOR MEMORY ANALYSIS HAS BEEN ASSESSED TO CONFIRM THE ANOMALY. THE FIELD REPRESENTATIVE STATED THE PATIENT WOULD RETURN FOR A MEMORY COLLECTION SO AS TO HAVE TECHNICAL SERVICE PERFORM AN ACCURATE ASSESSMENT OF BATTERY CONSUMPTION. THE DEVICE CURRENTLY REMAINS IMPLANTED AND IN SERVICE WITH NO ADVERSE PATIENT EFFECTS REPORTED AND NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16179 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 109273

    Patients

    Seq Age Sex Outcome Treatment
    1