BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4925291 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-13660
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    PRODUCT ID 3387S-40, LOT# V875361, IMPLANTED: 2012(B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S WIFE HAD NOTICED SWELLING ON FRIDAY PRIOR TO THE DATE OF THIS REPORT AND NOTIFIED THE HEALTHCARE PROFESSIONAL. ON SUNDAY PRIOR TO THE DATE OF THIS REPORT, THE PATIENT HAD GONE TO THE EMERGENCY ROOM DUE TO A CONFIRMED INFECTION IN THE AREA OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THIS WAS CONSIDERED A GRADUAL CHANGE. THE LEFT INS WAS GOING TO BE EXPLANTED ON THE DATE OF THIS REPORT DUE TO THE INFECTION. ADDITIONAL INFORMATION INDICATED THE INS AND EXTENSION WAS REMOVED. A CULTURE WAS TAKEN AND PATIENT WAS PUT ON ANTIBIOTICS. AS OF (B)(6) 2015 THE PATIENT WAS STILL ON ANTIBIOTICS AND INFECTION HAD NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468750 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention