BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3188464 · Received June 25, 2013

    Report

    Report Number
    3004209178-2013-10864
    Event Type
    Injury
    Date Received
    June 25, 2013
    Report Date
    June 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 37085-60, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V972376. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V972376. PRODUCT TYPE: LEAD: PRODUCT ID 37085-60, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V972376. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V972376. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED PATIENT HAD DEVICES REMOVED 3-4 MONTHS POST IMPLANT DUE TO INFECTION. THE PATIENT RECEIVED ANTIBIOTICS. THE PATIENT WAS IMPLANTED WITH A NEW SYSTEM AT A LATER DATE. PATIENT HAS A BILATERAL SYSTEM, SEE MFR 3004209178-2013-10863 FOR THE RELATED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287774 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention