BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2954813 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02466
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, 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 THAT FOR THE PAST 4 WEEKS, THE PATIENT'S STIMULATION HAD BEEN INTERMITTENT. THE PATIENT EXPERIENCED STIMULATION SHUTTING ON AND OFF IN ANY POSITION WHICH DID NOT CORRELATE WITH MOVEMENT, CHARGE LEVEL OF THE IMPLANTABLE NEUROSTIMULATOR (INS) OR WITH THE ENVIRONMENT. IT WAS NOTED TO HAPPEN EVERYWHERE AND THERE WAS NO KNOWN INCIDENT RELATED TO THIS. THE REPORTER STATED THAT THE PATIENT WOULD FEEL STIMULATION TURN ON AND OFF WHILE SITTING. CYCLING HAD NOT BEEN PROGRAMMED AND THE PATIENT HAD ALSO BEEN KEEPING THE INS CHARGED. THE PATIENT HAD TWO GROUPS; ONE WITH ADAPTIVE STIMULATION AND ONE WITHOUT. HOWEVER, STIMULATION WAS SHUTTING ON AND OFF WITH BOTH GROUPS. IT WAS NOTED THAT THE PATIENT'S SETTING WAS AROUND 3V. IMPEDANCE MEASUREMENTS WERE NORMAL, WITH IMPEDANCES IN RANGES OF 700 TO UPPER 900S AND NO OUT OF RANGE RESULTS. THE REPORTER INDICATED THAT ONE LEAD WAS PLACED LOWER FOR FRONT PELVIC PAIN AND THE OTHER LEAD WAS MORE MIDLINE. THE PATIENT FELT STIMULATION IN THE THIGH AREA, UP THE FRONT AND INTO THE ABDOMEN AREA ON THE RIGHT SIDE. WHEN STIMULATION STOPPED, IT STOPPED IN ALL OF THESE AREAS. ADDITIONAL INFORMATION RECEIVED 3 DAYS LATER INDICATED THAT THE PATIENT WASN'T REPROGRAMMED BECAUSE HER COVERAGE WAS GOOD. IT WAS BELIEVED THAT IT MAY HAVE BEEN PART OF THE HEALING PROCESS. THE REPORTER INDICATED THAT THE PATIENT WAS GOING TO WAIT IT OUT FOR A FEW WEEKS AND GO FROM THERE IF THE PROBLEM PERSISTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59834 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