BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA SC

    MDR report key: 2250658 · Received September 13, 2011

    Report

    Report Number
    3004209178-2011-07816
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE NEUROSTIMULATOR SITE. SPECIFICALLY, A STITCH WAS "POPPING" THROUGH THE SKIN AND THE PATIENT'S WIFE PULLED ON IT WITH A TWEEZERS. THE PATIENT'S CLINIC THEN TRIED TO CLEAN AND TREAT THE SITE BUT SUBSEQUENTLY EROSION AND AN INFECTION DEVELOPED. THE DEVICE WAS EXPLANTED AND THE PATIENT TREATED WITH ANTIBIOTICS. THE PATIENT WAS GOING TO BE RE-IMPLANTED IN (B)(6) 2011. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER REPORT #3007566237-2011-06181.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA SC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU104945V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NLA700648H| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LOT# UK6158147| UNKNOWN CONVERSION TYPE: MODEL LEADN,| UNKNOWN CONVERSION TYPE: MODEL LEADN,| EXTENSION: MODEL EXTENSION MVD, LOT# UNK| IMPLANTABLE NEURO STIMULATOR: MODEL 37602,| LOT# UK6157976