BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2604996 · Received June 8, 2012

    Report

    Report Number
    3004209178-2012-04234
    Event Type
    Injury
    Date Received
    June 8, 2012
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 3387S-40, LOT# V183416, IMPLANTED: (B)(6) 2009, EXPLANTED: UNKNOWN; EXTENSION: MODEL 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: UNKNOWN; ADAPTOR: MODEL 64001, LOT# N240186, IMPLANTED: (B)(6) 2010, EXPLANTED: UNKNOWN; PROGRAMMER: MODEL 37642, SERIAL# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL BEING TREATED BY INFECTIOUS DISEASE SPECIALISTS. IT WAS NOTED THAT HIS DEVICE WAS CHECKED SEVERAL DAYS BEFORE EXPLANT AND THE IMPEDANCES WERE FINE AND THE STIMULATION WAS PROVIDING BENEFIT TO THE PATIENT'S DYSTONIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS POCKET REVISED BY A PLASTIC SURGEON ON (B)(6) 2012. FOLLOWING THE REVISION THE PATIENT EXPERIENCED COUPLING AND COMMUNICATION ISSUES, THOUGH IT WAS NOTED THAT THERE WERE BANDAGES PRESENT OVER THE POCKET SITE. AN X-RAY WAS TAKEN, WHICH SHOWED THAT THE NEUROSTIMULATOR WAS FACING THE WRONG WAY AND WAS BEYOND THE RECOMMENDED DEPTH SPECIFICATIONS. THE PATIENT HAD ALSO DEVELOPED A SMALL INFECTION, WHICH WAS TREATED WITH ORAL ANTIBIOTICS. THE PATIENT WAS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2012, WHEN IT WAS DISCOVERED THAT THE INFECTION HAD PROGRESSED, AND THE ENTIRE SYSTEM WAS REMOVED. THE HOPE WAS TO RE-IMPLANT THE PATIENT AFTER A LONG COURSE OF IV ANTIBIOTICS FOLLOWED BY ORAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE INFECTIONS OVER THE PREVIOUS 2 YEARS BECAUSE OF EXPOSED WIRE. IT WAS BELIEVED THAT THE INFECTION WAS ASSOCIATED WITH A LEAD THAT ERODED THROUGH THE SKIN. THE PATIENT WAS VERY THIN. THE USE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS SUSPENDED. THEY PLANNED TO WAIT 3 MONTHS TO MAKE SURE THE INFECTION WAS FULLY CLEARED AND PLANNED TO RE-IMPLANT IN THE FUTURE WITH A SIMILAR NEUROSTIMULATOR SYSTEM. BECAUSE PATIENT WAS A DYSTONIA PATIENT AND WAS AT HIGHER PARAMETERS THAN PARKINSON'S, THE SURGEON BELIEVED THAT THE SYSTEMS COULD HOLD ONTO LOW GRADE INFECTIONS FOR A WHILE. THE ANTIBIOTIC THERAPY WAS GOOD AND THE INFECTION CLEARED AND FULLY HEALED. IT WAS REPORTED THAT EVERYTHING WAS WONDERFUL NOW.

    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 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention