BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3231918 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11901
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT # N287232, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3986A, LOT# N287232, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. IT WAS REPORTED THAT THE PATIENT WAS HAVING TELEMETRY ISSUES. IT WAS NOTED THAT THE PATIENT HAD LET THE IMPLANTABLE NEUROSTIMULATOR (INS) GO INTO OVERDISCHARGE. IT WAS FURTHER NOTED THAT THE PATIENT WANTED THE DEVICE REMOVED BUT THE DOCTOR WANTED THE PATIENT TO FIRST TRY TO RECHARGE AND REPROGRAM THE DEVICE. IT WAS NOTED THAT AN INS OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THAT DISSATISFACTION WITH STIMULATION WAS THE PRIMARY REASON FOR OVERDISCHARGE. IT WAS FURTHER NOTED THAT THE PATIENT DID NOT USE INS BECAUSE STIMULATION WAS TOO STRONG IN THE ARMS. IT WAS NOTED THAT THE PATIENT HAD CERVICAL LEAD FOR PAIN IN THE NECK. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WAS NOT SURE IF THE PATIENT EVER HAD REPROGRAMMING. IT WAS NOTED THAT THE PATIENT HAD AGREED TO BE REPROGRAMED AND THAT IS WHY THEY WERE TRYING TO RECHARGE THE INS. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WALKED THE PATIENT THOUGH HOW TO DO A PHYSICIAN MODE RECHARGE (PMR) OVER THE PHONE ON FRIDAY PRIOR TO REPORT. IT WAS NOTED THAT THE PATIENT WAS ABLE TO START CHARGING HER DEVICE. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WAS TO MEET WITH THE PATIENT ON MONDAY TO CLEAR POWER ON RESET (POR). IT WAS FURTHER NOTED THAT THE MANUFACTURING REPRESENTATIVE RECEIVED A CALL AT 2 AM SATURDAY MORNING FROM THE PATIENT¿S HUSBAND STATING THAT THE PATIENT WAS GETTING SHOCKED AND CONVULSING. IT WAS NOTED THAT THE PATIENT LOOKED LIKE SHE WAS HAVING SEIZURES. IT WAS NOTED THAT THE PATIENT NORMALLY ONLY FEELS STIMULATION IN THE NECK AND ARMS. IT WAS NOTED THAT THE PATIENT REPORTED ¿TOES WERE CURLING¿ AND ¿LEGS WERE BOUNCING.¿ IT WAS NOTED THAT THE PATIENT FELT STIMULATION FROM HEAD TO TOE AND COULD NOT WALK. IT WAS NOTED THAT THE PATIENT¿S HUSBAND TOOK HER TO THE HOSPITAL AND THE MANUFACTURING REPRESENTATIVE MET PATIENT ON SATURDAY MORNING AROUND 2 OR 3 AM. IT WAS FURTHER NOTED THAT WHEN THE MANUFACTURING REPRESENTATIVE ME THE PATIENT WITH THE PHYSICIAN PROGRAMMER THAT IT SHOWED THAT THE INS WAS OFF. IT WAS NOTED THAT THE STIMULATION WAS TOGGLED ON AND OFF AGAIN AND THAT THIS RESOLVED THE ISSUE. IT WAS NOTED THAT THE OVERSTIMULATION LASTED ¿ABOUT AN HOUR.¿ IT WAS NOTED THAT THE REASON FOR OVERSTIMULATION WAS UNKNOWN. IT WAS NOTED THAT IT WAS UNKNOWN WHETHER IF THE PATIENT WAS USING THE RECHARGER OR THE PATIENT PROGRAMMER AT THE TIME WHEN OVERSTIMULATION STARTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AWAKE AND ACTIVELY CHARGING JUST BEFORE OVERSTIMULATION OCCURRED. IT WAS NOTED THAT THE PATIENT NOTICED THAT THE BATTERY IN HER SCREEN WAS FULLY SHADED BLACK AND THEN OVERSTIMULATION HAPPENED. IT WAS FURTHER NOTED THAT THE PATIENT COULD NOT REMEMBER IF SHE HAD HIT THE OFF BUTTON ON THE CHARGING DEVICE BUT THAT SHE DID NOT THINK SO. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ERROR CODE THAT ACCOMPANIED THAT POR WAS UNKNOWN. IT WAS NOTED THAT THE CAUSE OF THE POR WAS THAT THE PATIENT WAS NOT USING STIMULATION OR CHARGING HER BATTERY, THEREBY PUTTING HER BATTERY INTO OVERDISCHARGE. IT WAS FURTHER NOTED THAT THE SYMPTOMS THAT THE PATIENT EXPERIENCED INCLUDED FULL BODY OVERSTIMULATION UPON CHARGING HER BATTERY. IT WAS NOTED THAT THE PATIENT WILL BE MEETING WITH THE DOCTOR TO HAVE THE SYSTEM REMOVED. THE PATIENT OUTCOME WAS NOTED AS ¿PATIENT IS GONE BUT WANTS THE SYSTEM EXPLANTED.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2014 VIA THE TELEPHONE FOR THE PURPOSE OF RECHARGING THE STIMULATOR BATTERY. THE PATIENT WAS INSTRUCTED OVER THE PHONE ON HOW TO "JUMP START" THE BATTERY. WITHIN A "COUPLE HOURS" OF THE PATIENT'S CONVERSATION WITH THE MANUFACTURER REPRESENTATIVE, THE STIMULATOR BEGAN TO "SEVERELY MALFUNCTION." THE STIMULATOR "WRONGLY AND CONTINUALLY" SHOCKED THE PATIENT EVERY TWO TO THREE SECONDS. PARAMEDICS WERE CALLED THE PATIENT'S HOME. THE PARAMEDICS NOTICED THAT THE PATIENT WAS "SHAKING AND HAD LOST MUSCLE CONTROL." THE REPORTER NOTED THAT "DUE TO THE EFFECTS OF THE CONTINUED ELECTRIC SHOCKS THE PATIENT WAS SHAKING TOO MUCH TO HAVE THE VITALS TAKEN." THE EMERGENCY ROOM PHYSICIANS NOTED THAT THE PATIENT WAS IN "EXTREME PAIN AND HAD RHYTHMIC JERKING OF HER ARMS AND LEGS EVERY COUPLE OF SECONDS." THE PHYSICIANS NOTED "GRAND MAL SEIZURES WITH CONVULSIONS, TOE CURLING, FULL BODY SPASMS AND SEIZING." THERE WAS AN EXPLANT DATE OF (B)(6) 2013 LISTED FOR THE INS AND LEAD. THERE WAS NO PATIENT DEATH. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING TO HAVE THE DEVICE REMOVED BUT THAT THE IMPLANT DOCTOR WAS NOT GOING TO BE REMOVING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331573 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention