BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2932709 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01066
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND STIMULATION WAS INTERMITTENT. STIMULATION WAS INITIALLY GOOD, BUT THEN THE PATIENT LOST STIMULATION THREE DAYS PREVIOUS TO THIS REPORT. NO KNOWN ACCIDENT OR INCIDENT WAS REPORTED IN RELATION TO THIS EVENT. PALPATING COULD CAUSE STIMULATION CHANGES. WHEN THE PATIENT WAS STANDING, THEY COULD NOT FEEL STIMULATION AT 10V UNLESS THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS PRESSED. IT WAS STATED THEN THEY COULD 'REALLY' FEEL STIMULATION IN TARGET AREA. IMPEDANCES GREATER THAN 10,000 OHMS WERE ALSO REPORTED. ELECTRODES 7 AND 15 WERE OUT OF RANGE, WHILE THE OTHER PAIRS WERE IN NORMAL RANGE (600-700 OHMS). WHEN USING ELECTRODES 0-7, THE PATIENT INITIALLY COULD FEEL STIMULATION WHILE SITTING, BUT WILL THEN LOSE STIMULATION SENSATION. STIMULATION COULD ONLY BE FELT USING ELECTRODES 8-15 IF THE PATIENT PUT PRESSURE ON THE INS. REPROGRAMMING WAS TRIED, BUT THAT 'HAD NOT ADDRESSED THE ISSUE.' ELECTRODES 7 AND 15 WERE NOT USED IN PROGRAMMING. ABOUT TWO AND A HALF WEEKS LATER IT WAS REPORTED THE PATIENT HAD SURGERY. THE LEADS AND BATTERY WERE CLEANED OFF. IT WAS STATED 'THERE WERE A FEW LEAD OUT OF IMPEDANCE.' IT WAS UNCLEAR IF THE REPORTER WAS REFERRING TO THE ELECTRODES. IT WAS FURTHER STATED THAT A DIFFERENT PROGRAM WAS USED. IT WAS INDICATED THE PATIENT WAS DOING 'GOOD.' A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED DURING THE PATIENT¿S LEAD REVISION PROCEDURE, THE PHYSICIAN REPORTED ¿HE MAY HAVE SEEN SOME OLD BLOOD IN THE SOCKET.¿ IT WAS NOTED THE PHYSICIAN ¿DID INSERT AND WIPE SEVERAL TIMES¿ AND THE PHYSICIAN WAS NOTED TO HAVE BEEN ¿UNSURE IF HE GOT ALL THE BLOOD OUT.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT ELECTRODES 3, 4, 7, 8, 14, AND 15 WERE ALL >10,000 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39395 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 Required Intervention