BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3880269 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11732
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    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

    PRODUCT ID 3387S-40, LOT# VA09FZ1, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# VA09FZ1, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS SKIN BREAKDOWN NOTED IN THE INFERIOR PORTION OF THE SKIN AROUND THE BATTERY. IT WAS STATED A REVISION OCCURRED. IT WAS NOTED, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN THE RIGHT CHEST AND A POCKET REVISION WAS PERFORMED. IT WAS NOTED THE EXTENSIONS WERE DISCONNECTED FROM THE BATTERY AND THE BATTERY WAS MOVED TO THE RIGHT AXILLARY AREA. IT WAS NOTED, THE ELECTRODE IMPEDANCE CHECK WAS PERFORMED AND ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS STATED A GRAM STAIN WAS OBTAINED AND THE CULTURE WAS SENT. IT WAS NOTED, THE PATIENT HAD NOTICED THE SKIN STARTING TO BREAKDOWN AROUND THE INFERIOR PORTION OF THE BATTERY ON THE MEDIAL SIDE. IT WAS STATED, THE AREA WAS RED AND INFLAMED. IT WAS NOTED, THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS FURTHER REPORTED, THE PATIENT RECEIVED EFFECTIVE THERAPY. IT WAS NOTED, THE RESULTS OF THE CULTURE WAS UNKNOWN. IT WAS NOTED, THE PATIENT WAS TREATED WITH ANTIBIOTICS IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358013 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other| R