BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3233195 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11940
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4): PRODUCT TYPE RECHARGER; PRODUCT ID 3998, LOT# V011457, IMPLANTED: (B)(6) 2007: PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007: PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED THE THERAPY OFF AND THE DEVICE TURNED ITSELF BACK ON. IT WAS NOTED THIS HAD BEEN HAPPENING FOR ¿A WHILE.¿ PATIENT HAD A TINGLING SENSATION THAT COMES AND GOES WHEN THE THERAPY HAD BEEN TURNED OFF. PATIENT HAD VERIFIED WITH THE PATIENT PROGRAMMER THAT THE DEVICE TURNED BACK ON BY ITSELF. THERAPY IS OFF BUT PATIENT COULD FEEL STIMULATION IN HER RIGHT LEG FROM THE KNEE DOWN TO THE FOOT. DEVICE HAD NOT BEEN CHECKED IN MANY YEARS. A MANUFACTURING REPRESENTATIVE ADJUSTED THE DEVICE ABOUT TWO YEARS PRIOR TO THE REPORT. THERE HAD BEEN NO FALLS OR TRAUMAS RECENTLY. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT AN APPOINTMENT WITH PHYSICIAN HAD BEEN MADE FOR THE PATIENT, BUT IT HAD BEEN CANCELLED AS THE PATIENT HAD RECEIVED INFORMATION FROM MANUFACTURE REPRESENTATIVE ON HOW TO USE THEIR PATIENT PROGRAMMER. IT WAS NOTED THAT THERE HAD BEEN NO DEVICE ISSUE, AS THE PATIENT HAD JUST NOT UNDERSTOOD THE ¿ON/OFF¿ OF THE REMOTE VERSUS THE ¿ON/OFF¿ OF THE ACTUAL IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS FURTHER REPORTED THAT THE ISSUE WAS RESOLVED, AND HAD BEEN SINCE THE DAY AFTER THE INITIAL REPORT. ADDITIONALLY, THERAPY WAS REPORTED TO HAVE BEEN ¿GREAT¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333751 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR