BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD X2

    MDR report key: 1040267 · Received May 8, 2008

    Report

    Report Number
    6000153-2008-02463
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF FINAL DEVICE ANALYSIS WERE NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN PRODUCT EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A SCAB FOUR MONTHS AGO OVER THE RIGHT-SIDED CRANIAL IMPLANT SITE; THE PATIENT SUFFERED REPORTED FALLS AND TRAUMA INJURY TO THE HEAD (HITTING HIS HEAD), OVER A THREE MONTH PERIOD. THERE WAS A PROGRESSION OF THE SCALP WOUND EROSION RESULTING IN INFECTION WITH SYMPTOMS OF INTERMITTENT FEVERS AND DRAINAGE. THE PATIENT WAS DIAGNOSED WITH STAPHYLOCOCCUS AUREUS (MSSA), AND SEPTIC ARTHRITIS AFTER COMPLETION OF WOUND CULTURES AND UNSPECIFIED LABORATORY TESTING. HE WAS ADMITTED TO THE HOSPITAL FOR EVALUATION AND TREATMENT WITH ORAL ANTIBIOTICS. INSPECTION SHOWED THE SCAB WAS LOOSE FROM THE SCALP WITH UNDERLYING "WHITISH" TISSUE; THERE WAS SLIGHT DRAINAGE FROM THE WOUND AND NO EXPOSED WIRE WAS VISIBLE. THE OTHER DBS SURGICAL SITES HAD BEEN DEEMED INTACT. THE SYSTEM WAS EXPLANTED; AFTER REMOVAL OF THE LEAD AND EXTENSION PRODUCTS, THE PULSE GENERATOR WAS EXPLANTED FOUR DAYS LATER. THE EVENT WAS ATTRIBUTED TO THE PATIENT CONDITION AND INCLUDED RISK FACTORS OF ANOTHER PRIMARY INFECTION, ORTHOPEDIC LIMITATIONS FROM PARKINSON'S DISEASE AND FROM PATIENT INDUCED "PICKING AT THE IMPLANT SITE". THE PATIENT WAS EXPECTED TO RECOVER. REFER TO MFR REPORT #6000153-2008-02464 AND 6000153-2008-02465.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD X2 MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J0421701V

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R SELEGILINE| AMANTADINE| DICLOXACILLIN| ASPIRIN| METOPROLOL| FERROUS SULFATE| SINEMET| EXPLANTED| LISINOPRIL| LORAZEPAM| SERTRALINE| OXYBUTYNIN| IMPLANTABLE NEURO STIMULATOR MODEL 7428| LOT # NFD101131H| ACCESSORY STIMLOC MODEL UNK| EXPLANTED| IMPLANTED| RANITIDINE| PRAMIPEXOLE| SIMVASTATIN| ENTACAPONE