BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3233775 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11968
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 27, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A BURNING SENSATION AT THE POCKET SITE AND IN HIS LEFT LEG FOLLOWING A FALL ON HIS LEFT SIDE A COUPLE MONTHS PRIOR TO REPORT. IT WAS STATED SINCE THE FALL THE PATIENT HAD ALSO HAD A ¿MAJOR RASH¿ ALL OVER HIS BODY, BUT MAINLY ON HIS BACK WHICH TURNED TO WELTS AND WAS REALLY BAD WHEN HE SWEAT. IT WAS NOTED THE RASH WAS GETTING SO BAD THE PATIENT CONSIDERED GOING TO THE EMERGENCY ROOM BUT DID NOT. IT WAS STATED THE PATIENT HAD NOT CHANGED THE TYPE OF CLOTHES HE WORE OR THE WAY HE WASHED. HOWEVER, IT WAS ALSO NOTED THE DEVICE STILL HELPED MANAGE HIS PAIN. ADDITIONALLY, THE PATIENT PLANNED TO SEE A NEW PAIN MANAGEMENT HEALTHCARE PROVIDER ON (B)(6) 2013 WHO WILL TAKE HIM OFF OF METHADONE AND POSSIBLY PRESCRIBE SOMETHING FOR THE RASH. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD FALLEN THREE TIMES SINCE IMPLANT. IT WAS NOTED THAT AT TIMES THE STIMULATION IS REALLY INTENSE AND AT OTHER TIMES THE STIMULATION IS NOT AS INTENSE. PATIENT ALWAYS STAYED IN SAME POSITION FOR 3-5 MINUTES BEFORE CHANGING POSITIONS. PATIENT FELT A BURNING PAIN NEAR THE BATTERY SITE SINCE THE PATIENT HAD FALLEN. PATIENT WAS UNABLE TO REMEMBER EXACTLY WHEN THE FALL HAD TAKEN PLACE. DEVICE HAD NOT BEEN CHECKED SINCE THE FALL. IT WAS NOTED THAT WHEN THE DEVICE WAS INTENSE THE PATIENT FELT LIKE HIS BODY WOULD JUMP. PATIENT¿S LEGS JUMP WHEN HE WAS LYING IN BED. IT WAS NOTED THAT AT TIMES PATIENT WOULD NOT SLEEP WELL BUT AT OTHER TIMES THE PATIENT WOULD SLEEP FOR 14 HOURS AT A TIME. THE PATIENT WAS TAKING OXYCODONE FOR ORAL PAIN MEDICATION, HE TAKES 30MG EVERY SIX HOURS BUT PATIENT DID NOT THINK THE PAIN MEDICATION WAS DOING THE JOB. IT WAS FURTHER NOTED THAT THE PATIENT HAD STOPPED TAKING METHADONE. PATIENT WAS ALSO TAKING 7.5MG MALOXOCAM AN ANTI-INFLAMMATORY ONCE A DAY AND TWO 2MG TIZANINDINE A MUSCLE RELAXER AT BED TIME. PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334399 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR