BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2830582 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10204
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 16, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED STIMULATION WAS IN THE WRONG LOCATION. STIMULATION HAD BEEN GOING DOWN THE PATIENT'S LEGS MORE SO THAN WHERE THEY NEEDED IT, WHICH WAS IN THE TAILBONE AREA. THE PATIENT HAD TURNED UP THE STIMULATION AND GOTTEN MORE SENSATION IN THEIR LEGS. IT WAS ALSO NOTED THE PATIENT ALSO OFTEN HAD NO SENSATION, BUT WHEN THEY HAD ARCHED THEIR BACK OR CHANGED POSITIONS THEY HAD SENSATION. PATIENT WANTED TO BE REPROGRAMMED. IT WAS ALSO NOTED THE PATIENT BELIEVED THEIR RECHARGER MAY HAVE HAD ISSUES. PATIENT HAD NEVER CHARGE IT TO 100% CHARGED. THE PATIENT'S BATTERY CHARGES AND WAS WORKING BUT THEY HAD JUST NEVER SEEN THE 'FULL CHARGE' SCREEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TO KEEP MOVING HER BODY TO GET STIMULATION. THE PATIENT HAD TO SUCK HER STOMACH IN, TIGHTEN HER BUTTOCKS, ARCH HER BACK, OR USE A PILLOW TO PUT PRESSURE ON HER BUMP TO GET STIMULATION. THE PATIENT STATED SHE REALIZED THAT IT WAS STILL HEALING AND WOULD TAKE TIME FOR STIMULATION TO STABILIZE ALONG WITH FURTHER PROGRAMMING, BUT HAS HAD THE ISSUE SINCE IMPLANT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE. HOWEVER, IT WAS UNCLEAR IF SHE SOUGHT HELP OR NOT. IT WAS MARKED THAT THE PATIENT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE FOR HELP AND THAT HER DOCTOR WOULD NOT SEE HER BECAUSE SHE TESTED POSITIVE FOR ALCOHOL AT HER LAST URINE TEST. IT WAS ALSO MARKED THAT THE PATIENT HAD NOT SOUGHT FURTHER HELP. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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