BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA SC

    MDR report key: 2210309 · Received August 9, 2011

    Report

    Report Number
    3007566237-2011-06181
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN INFECTION WAS REPORTED AT THE NEUROSTIMULATOR LOCATION FOLLOWING IMPLANT. A STITCH WAS POPPING THROUGH THE SKIN AND THE PT'S WIFE PULLED THE STITCH WITH A TWEEZER. THE HEALTH CARE PROVIDER TRIED TO CLEAN AND TREAT THE AREA, BUT AN INFECTION WAS PRESENT AT THE EROSION SITE. THE PT WAS AT THE CLINIC IN FAIR CONDITION. IT WAS DECIDED TO EXPLANT THE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA SC MHY MEDTRONIC NEUROMODULATION 37602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| IMPLANTED:| LOT# NFW140717H| LOT# NFW145135H| IMPLANTED: