BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD (X2)

    MDR report key: 1059903 · Received June 12, 2008

    Report

    Report Number
    6000153-2008-03140
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPEATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BILATERAL SUBTHALAMIC NUCLEUS (STN) STAGE 1 LEAD IMPLANTATION, THE FIRST MICROELECTRODE RECORDING (MER) TRACK PROVIDED POSITIVE FEEDBACK (QUALITY STN SIGNALS, TREMOR CELLS IN THE AREA). THE FIRST LEAD WAS POSITIONED. TEST STIMULATION, USING A TEST STIMULATOR DEVICE, REVEALED THE PATIENT DID NOT RECEIVE CLEAR TREMOR SUPPRESSION; THERE WERE NO CLEAR SIDE EFFECTS UP TO 10 VOLTS. A DIFFERENT TEST STIMULATOR AND A DIFFERENT TEST STIMULATION CABLE WERE USED. THERE WAS NO PATIENT IMPROVEMENT. THE LEAD WAS MOVED TO A MORE LATERAL/POSTERIOR POSITION. ANOTHER MER TRACK WAS PERFORMED. THE FIRST LEAD WAS POSITIONED AGAIN. SIMILAR TEST RESULTS WERE OBTAINED. UPON REMOVAL OF THE LEAD, BLOOD WAS NOTICED INSIDE THE LEAD BODY. A THIRD MER TRACK WAS PERFORMED. A NEW (SECOND) LEAD WAS PLACED IN TO THE TRACK. THE TEST STIMULATION WAS INEFFECTIVE. A FOURTH POSITION WAS ATTEMPTED. THE FOURTH TRACK DID NOT PRODUCE POSITIVE TEST STIMULATION RESULTS. UPON REMOVAL OF THE SECOND LEAD BLOOD WAS NOTICED INSIDE THE BODY OF THE LEAD. THE BLOOD INSIDE THE LEADS WAS NOTED FROM THE TIP OF THE LEAD UP PROXIMALLY 3 CM. THE END OF THE LEAD TIP LOOKED GOOD, ROUNDED, AND INTACT. THE PATIENT HAD BEEN SCHEDULED FOR A BILATERAL CASE, BUT AFTER SEVERAL ATTEMPTS TO GET SYMPTOM SUPPRESSION ON THE FIRST SIDE, THE DECISION WAS MADE TO END THE PROCEDURE AND TRY AGAIN AFTER FURTHER IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD (X2) MHY MEDTRONIC PUERTO RICO OPEATIONS CO. 3389 V096181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LEAD: MODEL 3389 LOT# V096181| IMPLANTED:| EXPLANTED: