BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 12113344 · Received July 3, 2021

    Report

    Report Number
    2124215-2021-14281
    Event Type
    Injury
    Date Received
    July 3, 2021
    Date of Event
    May 12, 2021
    Report Date
    March 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE UNDERWENT DETAILED ANALYSIS. VISUAL INSPECTION DID NOT SHOW ANY ABNORMALITIES. REVIEW OF THE DEVICE MEMORY CONFIRMED IT WAS IN SAFETY MODE. THE BATTERY WAS DISCONNECTED FROM THE HYBRID ASSEMBLY AND TESTING INDICATED THE BATTERY VOLTAGE WAS NORMAL. WITH ANY HARDWARE BEING RULED OUT FOR THE POINT OF FAILURE, IT WAS DETERMINED THAT A FORM OF SOFTWARE CORRUPTION HAD CAUSED THE DEVICE TO ENTER SAFETY CORE. THE ROOT CAUSE OF THE SOFTWARE CORRUPTION IN THIS DEVICE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. DEVICE REPLACEMENT WAS RECOMMENDED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. DEVICE REPLACEMENT WAS RECOMMENDED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT IS EXPECTED TO BE RETURNED BACK FROM THE FIELD FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010994 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 109783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H| R