BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 14032585 · Received April 6, 2022

    Report

    Report Number
    2124215-2022-09695
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    January 5, 2022
    Report Date
    April 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813086 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 295230

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R