BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4132332 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14403
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY A FEW WEEKS POST-IMPLANT, THE PATIENT WITH THIS DEVICE DEVELOPED A LOCALIZED INFECTION. AS A RESULT, THE PATIENT RETURNED FOR MEDICAL INTERVENTION WHICH CONSISTED OF A ONE DAY ADMISSION FOR PRODUCT REMOVAL AND REIMPLANTATION, OF THE SAME DEVICE. NO ADDITIONAL INTERVENTION WAS REQUIRED AND NO ADVERSE EFFECTS WERE REPORTED. TO DATE, THE DEVICE REMAINS IMPLANTED AND IN SERVICE WITH NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612201 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND J277

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R J277