BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2882402 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12116
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    July 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-60, SERIAL# (B)(4), PRODUCT TYPE EXTENSION, PRODUCT ID 37085-60, SERIAL# (B)(4), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V411439, PRODUCT TYPE LEAD, PRODUCT ID 3387S-40, LOT# V680690, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE SET WAS REMOVED DUE TO AN INFECTION AND WAS IMPLANTED WITH A NEW DEVICE SET 6 MONTHS LATER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PRIMARY SITE OF THE INFECTION WAS THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. IT WAS NOTED THAT HE PATIENT EXPERIENCED SYMPTOMS OF REDNESS, SWELLING, DRAINAGE, AND POCKET EROSION. CULTURES WERE TAKEN OF THE SITE BUT THE RESULTS WERE REPORTED AS UNKNOWN. TREATMENTS INSTITUTED FOR THE INFECTION WERE BOTH IV AND ORAL ANTIBIOTICS. THE PATIENT OUTCOME WAS REPORTED AS INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Required Intervention