BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3212547 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11473
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748240, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0222877V, PRODUCT TYPE: LEAD. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748240, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0337444V, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ¿DUE TO INFECTION.¿ IT WAS ADDITIONALLY NOTED THE PATIENT¿S POCKET INCISION DEVELOPED ¿KELOID-TYPE SCARS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313900 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention