BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3872120 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01637
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3777, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE THORACIC LEAD FOUND NO SIGNIFICANT ANOMALY. FUNCTIONAL TESTING OF THE LEAD FOUND NO SHORTS AND CONTINUITY WAS ACCEPTABLE. THE PROXIMAL END OF THE OUTER INSULATION OF THE LEAD WAS STRETCHED AND BROKEN. THIS WAS CONSISTENT WITH EXPLANT DAMAGE. ANALYSIS OF THE CERVICAL LEAD FOUND THE #0 ELECTRODE HAD BROKEN OFF. CONTINUITY WAS ACCEPTABLE ON CIRCUITS 1 THROUGH 7 DURING FUNCTIONAL TESTING. CIRCUIT 0 HAD AN OPEN. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PREVIOUSLY HAD GOOD STIMULATION AND RELIEF. HOWEVER, THE PATIENT HAD ¿QUITE A SEVERE FALL¿ AND AFTERWARDS, STIMULATION WAS LOST AND THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IMPEDANCES ON BOTH LEADS WERE ALSO OUT OF RANGE. DURING A SURGICAL PROCEDURE TO REVISE THE LEADS, IT WAS SEEN THAT THE THORACIC ELECTRODE WAS BROKEN. THE TIP OF THE CERVICAL LEAD HAD BROKEN OFF AND HAD MIGRATED INTO THE PATIENT¿S UPPER CERVICAL EPIDURAL SPACE. THE TIP COULD NOT BE SALVAGED AT THAT TIME. ¿ALL OTHER LEADS¿ WERE REMOVED AND 2 NEW LEADS WERE IMPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL. TWO DAYS LATER IT WAS REPORTED THAT THE "MASSIVE HEAVY" FALL RESULTED IN THE LEADS BEING DISLODGED. AFTER THE FALL, THE PATIENT¿S CERVICAL STIMULATION ¿COMPLETELY CHANGED¿. THE PATIENT WAS GETTING ¿SERIOUS MUSCLE TWITCHES¿ IN HER ARMS WITH STIMULATION AND IT WAS NOT REDUCING THE PAIN. THE STIMULATION WAS ACTUALLY ¿A BIT PAINFUL¿. X-RAYS WERE TAKEN AND IT WAS DISCOVERED THAT, THE NUMBER 8 CONTACT AT THE TOP WAS ¿VERY ANTERIORLY¿ ORIENTED AT ¿ABOUT 45 DEGREES TO THE REST OF THE LEAD¿. THE PHYSICIAN THEREFORE CAME TO THE CONCLUSION THAT, IN VIEW OF THE SYMPTOMS AND PROBLEM WITH STIMULATION, THE LEAD HAD ¿MOST PROBABLY¿ PENETRATED THE DURA AND WAS NOW LYING INTRATHECALLY (NOT THE WHOLE ELECTRODE, JUST THE NUMBER 8 CONTACT). IT WAS FELT THAT BETTER STIMULATION WOULD BE ACHIEVED IF THE ELECTRODE WAS A ¿LITTLE BIT LOWER¿. DURING THE SURGERY TO REPOSITION THE ELECTRODES, THE THORACIC ELECTRODE WAS REPOSITIONED WITHOUT ANY PROBLEMS. WHEN LOOSENING THE ANCHOR OF THE CERVICAL ELECTRODE, THE ELECTRODE WAS, BY WORKING ON THE ANCHOR, ACCIDENTALLY WITHDRAWN ¿TOO MUCH¿, AND IT WAS DECIDED TO WITHDRAW THE ELECTRODE COMPLETELY AND TO RE-INSERT IT. THE LEAD WAS ACCIDENTALLY WITHDRAWN, THEN COMPLETELY WITHDRAWN WITH EASE AND WITHOUT EFFORT OR TRACTION. THE ELECTRODE WAS RE-INSERTED, AND WHEN TESTED, ¿JUST A STRIPE¿ WAS FOUND AT ELECTRODE NUMBER 8. ALL THE OTHERS WERE REPORTEDLY INVALID. IT WAS INITIALLY THOUGHT THAT IT WAS DUE TO ¿HIGH FLUID¿ DUE TO THE INSERTION OF THE ELECTRODE. ON CLOSER LOOK HOWEVER, IT WAS NOTICED THAT THERE WERE ONLY 7 CONTACT POINTS ON THE LEAD. ON FURTHER INVESTIGATION, IT WAS FOUND THAT THE TIP CONTACT POINT (NUMBER 8) WAS SITTING HIGH UP IN THE EPIDURAL SPACE OPPOSITE C2 ON THE RIGHT HAND SIDE AND WAS COMPLETELY DETACHED FROM THE REST OF THE LEAD. THE ELECTRODE HAD BROKEN, ¿MAYBE DUE TO THE FALL¿. A NEW ELECTRODE WAS INSERTED AND WAS LEFT IN PLACE. THE PATIENT HAD BEEN FOLLOWED-UP ON FOR 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349345 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R