BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE EXTENSION

    MDR report key: 1013826 · Received March 14, 2008

    Report

    Report Number
    6000153-2008-01248
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE PT UNDERWENT A SURGICAL PROCEDURE TO DEBRIDE AN AREA OF SKIN BREAKDOWN ON THE RIGHT SIDE OF HIS HEAD BEHIND HIS EAR WHERE THE EXTENSIONS HAD CAUSED IRRITATION. IT HAD BEEN THE SECOND OR THIRD TIME THAT HE HAD UNDERGONE THIS TYPE OF DEBRIDEMENT FOR THE SAME SITE DESPITE TESTING NEGATIVELY FOR SIGNS OF INFECTION. AFTER THE MOST RECENT PROCEDURE, THE PT REPORTED A RETURN OF TREMOR IN HIS RIGHT HAND AND VARIOUS SHOCKING SENSATIONS ON THE RIGHT SIDE OF THIS BODY FROM HIS FACE TO HIS FOOT. HIS NEUROLOGIST ADVISED THE PT TO TURN OFF HIS NEUROSTIMULATOR UNTIL THE SYSTEM COULD BE EVALUATED. ON FOUR DAYS LATER, THE PT WAS STILL IN THE HOSPITAL AND ELECTRODE IMPEDANCE TESTING REVEALED OPEN CIRCUITS, ALL UNIPOLAR IMPEDANCES SHOWED >4000 OHMS. THE IMPEDANCES WERE REPEATED SEVERAL TIMES AT VARIOUS PARAMETERS WITH THE SAME RESULT. ALL THE IMPEDANCES FOR THE RIGHT BRAIN LEAD WERE WITHIN NORMAL LIMITS. LATER THAT DAY, X-RAYS WERE REVIEWED AND IT APPEARED TO INDICATE A KINKED OR BROKEN LEAD THAT CORRESPONDED TO THE LEFT BRAIN IMPLANT. ABOUT THE SAME TIME, THE HCP RECEIVED LAB RESULTS WHICH INDICATED THAT THE PT'S HEAD/NECK WOUND TESTED POSITIVE FOR AN INFECTION. THE PLAN WAS TO REMOVE ALL OF THE PT'S IMPLANTS THE FOLLOWING WEEK, TREAT THE INFECTION WITH A COURSE OF ANTIBIOTICS, AND LOOK AT REPEATING SURGERY IN A COUPLE OF MONTHS. SEE MANUFACTURER'S REPORT #6000153200801247. APPROX 3 WEEKS LATER, THE PT'S WIFE REPORTED THAT THE SYSTEM WAS REMOVED DUE TO EROSION AND THE PT HOPED TO HAVE THE DEEP BRAIN STIMULATION SYSTEM IMPLANTED AGAIN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE EXTENSION MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED| IMPLANTED| IMPLANTED| PROGRAMMER MODEL 7436| EXPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3387S| EXPLANTED| LEAD MODEL 3387S| EXTENSION MODEL 7482| NEUROSTIMULATOR MODEL 7428