BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 414542 · Received August 29, 2002

    Report

    Report Number
    MW1026032
    Event Type
    Malfunction
    Date Received
    August 29, 2002
    Date of Event
    July 23, 2002
    Report Date
    July 30, 2002
    Manufacturer
    MEDTRONIC NEUROLOGICAL
    Product Code
    MUV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 11-21-02: MFR HAS NOT RECIEVED THE DEVICE FOR ANALYSIS. THEY DO NOT RECOMMEND CAPPING THE LEAD OR STAGED IMPLANTS. THEY DO RECOMMEND THE FOLLOWING FOR ASSEMBLY OF EITHER THE EXTENSION OR THE PERCUTANEOUS EXTENSION TO THE LEAD: TIGHTEN EACH SET SCREW SLOWLY UNTIL RESISTANCE IS FELT THEN TIGHTEN ONE HALF TURN FURTHER. CAUTION OVER TIGHTENING THE SETSCREWS CAN RESULT IN DAMAGE TO THE LEAD TO THE EXTNESION. FOR DISASSEMBLY, THEY RECOMMEND THE FOLLOWING: LOOSEN ALL SET SCREWS COMPLETELY, GENTLY PULL ON THE CONNECTION, IF RESISTANCE IS FELT CHECK ALL SETSCREWS AND ENSURE THAT ALL ARE LOOSENED APPROPRIATELY. THE CURRENT STATUS OF THE DEVICE IS ACCORDING TO THE REPORT, REMAINS IMPLANTED. NO CHANGES TO THE DEVICE RELATED TO THE EVENT.

    Description of Event or Problem · 1

    DEEP BRAIN STIMULATOR WAS PLACED INTO LT VIM THALAMUS WITH PROXIMAL LEAD TUNNELED UNDER SKIN AND PROTECTED WITH THE DISTAL END OF THE PERCUTANEOUS EXTENSION BOOT (CUT OFF AND PLACED OVER LEAD, SCREWED DOWN LIGHTLY) TO PROTECT DISTAL LEAD FROM INJURY DURING RE-OPERATION. TAKEN BACK TO OR TWELVE DAYS LATER. LEAD (DISTAL) EXTERNALIZED AND BOOT REMOVED. DURING UNSCREWING OF SET SCREWS, THE METAL SCREW TORQUED THE ENTIRE METAL DEVICE WITHIN THE BOOT 90 DEGREES, FRACTURING THE LEAD AT THE DISTAL END BETWEEN CONTACT 2 AND 3. BOOT THEN CUT OFF THE LEAD, DAMAGE INSPECTED. STILL ABLE TO GET LEAD (WITH FX INTO PERMANENT CONNECTOR HOUSING WITH APPROPRIATE METAL/METAL CONTACTS. DEVICE IMPLANTED. PT RETURNED THREE DAYS LATER FOR DBS PROGRAMMING WITH GOOD TREMOR CONTROL, NO SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC * MUV MEDTRONIC NEUROLOGICAL 3387 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other