BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2780940 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09073
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-39, LOT# N319577, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPROGRAMMING WAS DONE "SEVERAL TIMES" AND "EVERYTHING LOOKED NORMAL." THE FOLLOWING DAY, IT WAS REPORTED THE PATIENT WAS "STABLE FOR NOW." THE PATIENT WAS GIVEN ORAL MEDICATIONS IN OCTOBER. IT WAS STATED THE PATIENT ONLY USED STIMULATION "PART TIME." IT WAS NOTED THAT ALL TESTS GIVEN CAME BACK WITH "NOTHING REMARKABLE." IT WAS INDICATED THAT THE ABDOMINAL ISSUES HAD RESOLVED, BUT IT WAS UNCLEAR IF THE DORSAL ROOT STIMULATION WAS STILL AN ISSUE. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL EXPERIENCING ABDOMINAL AND LEG CONTRACTIONS WHEN STIMULATION WAS ON. IT WAS NOTED THAT THE PATIENT STILL FELT STIMULATION IN THE UPPER EXTREMITIES EVEN THOUGH THE LEAD WAS IN THE THORACIC AREA. IT WAS ALSO NOTED THAT THE PATIENT SENT A VIDEO FILE, WHICH DEMONSTRATED THE EFFECTS OF THE LEG AND ABDOMINAL CONTRACTIONS WITH WHAT WAS BELIEVED TO BE INCREASED PULSE WIDTH. IT WAS ALSO NOTED THAT THE PATIENT ONLY MADE IT TO "30" BEFORE HE HAD TO TURN THE STIMULATION OFF. IT WAS ALSO REPORTED THAT THE PATIENT STILL THOUGHT THE STIMULATION WAS IMPACTING HIS CARDIAC FUNCTION, BUT DETAILS WERE UNKNOWN. ADDITIONAL INFORMATION RECEIVED IN OCTOBER REPORTED THAT THE PATIENT SCHEDULED AN APPOINTMENT WITH THE IMPLANTING PHYSICIAN TO DISCUSS NEXT STEPS. IT WAS NOTED THAT THE PATIENT MAY NEED TO BE REPROGRAMMED (ANALYZE EXISTING ELECTRODE PATTERNS). THE REPORTER STATED THAT RECENT X-RAYS SUGGESTED THE PATIENT WAS RECEIVING DORSAL ROOT STIMULATION, WHICH WOULD CAUSE UNPLEASANT STIMULATION. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, THE PATIENT FELT AS THOUGH HIS STIMULATION WAS "PACING" HIS HEART AND IMPACTING HIS HEART RATE. THE PATIENT WAS MEDICAL DOCTOR. HE CHECKED HIS HEART RATE WITH ELECTROCARDIOGRAPHY (EKG). THE EKG WAS ALSO DONE WITH PATIENT'S PAIN DOCTOR. THERE WAS NO IMPACT ON HIS HEART RATE AS THE STIMULATION RATE WAS CHANGED BETWEEN 2 HERTZ TO 120 HERTZ. THE STIMULATION WAS REPORTED TO BE IN THE WRONG LOCATION. THE PATIENT WAS FEELING STIMULATION IN THE ARMS AND HANDS. HE ALSO FELT CONTRACTIONS AND THROBBING WEAKNESS IN HIS ABDOMINAL AREA AND DOWN HIS LEGS. THE PAIN IN THE LEFT LEG WAS WORSE THAN THE RIGHT LEG. IT WAS NOTED THAT THE DAY AFTER IMPLANT, PATIENT HAD LEAD REVISION WHERE THE LEAD WAS PULLED DOWN BECAUSE THE STIMULATION WAS IN ARMS AND HANDS. THE LEAD WAS PULLED DOWN A HALF TO A FULL VERTEBRAL LEVEL TO T10 AND LOWER (FROM T9-10 TO T9-10-11 LEVEL), AND IT WAS PLACED IN THE MIDLINE. THE PATIENT STILL HAD STIMULATION IN ARMS AND HANDS. THE ABDOMINAL STIMULATION WENT AWAY AS THE LEAD WAS PULLED DOWN. THE STIMULATION WAS HELPING PATIENT WITH HIS PAIN. THE PATIENT WAS PROGRAMMED POST-OPERATION AND AT POST-IMPLANT FOLLOW-UP. IT WAS NOTED THAT PATIENT HAD UNUSUAL TRIAL. A "TRIPOLE ARRANGEMENT" OF LEADS WAS USED AND PATIENT EXPERIENCED STIMULATION IN THE UPPER EXTREMITIES DURING TRIAL. IT WAS LATER REPORTED THAT WHEN THE STIMULATION WAS TURNED ON, PATIENT HAD ABDOMINAL CONTRACTIONS. THE CONTRACTION CONTINUED AS THE STIMULATION WAS TURNED UP. IT WAS SUSPECTED THAT PATIENT WAS GETTING MOTOR STIMULATION AND A LEAD HAD MIGRATED LATERALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention