BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3130331 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08158
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 6, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THE PATIENT WAS NOT CURRENTLY FEELING STIMULATION. IT WAS STATED, THE PATIENT WAS HAD A SHOCK WHEN THE DEVICE WAS TURNED UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS EITHER TOO HIGH OR TOO LOW. IT WAS STATED THAT THE PATIENT WAS "HAVING AN AWFUL TIME". IT WAS REPORTED THAT THE PATIENT ALMOST "CAME OFF THE BED WHEN HER HUSBAND STARTED TO CHANGE THE SETTING ON HER DEVICE." IT WAS STATED THAT "THE MACHINE IS NOT DOING ANYTHING." IT WAS NOTED THAT THE PATIENT NEEDED MORE STIMULATION IN HER LEFT LEG. IT WAS ALSO REPORTED THAT "THE MACHINE WAS NOT WORKING". DURING TROUBLESHOOTING THE PATIENT SCREAMED AND ASKED FOR THE STIMULATION TO BE TURNED DOWN. THE PATIENT WAS NOT FEELING STIMULATION ON HER LEFT SIDE WITH GROUP A AND SHE DIDN¿T FEEL STIMULATION ON HER RIGHT SIDE WITH GROUP B. ADDITIONAL INFORMATION RECEIVED ABOUT TWO WEEKS LATER REPORTED THAT THE PATIENT HAS HAD "MORE TROUBLE AND PAIN SINCE IMPLANT." THE PATIENT TAKES 5 MG OF OXYCODONE FOR THE PAIN, BUT IT WAS NOT HELPING. THE PATIENT WAS IN THE DOCTOR'S OFFICE ON (B)(6) 2013 AND MET A MEDTRONIC REPRESENTATIVE FOR REPROGRAMMING, BUT THAT DID NOT HELP. IT WAS STATED THAT THE PATIENT "CAN'T DO ANYTHING BUT LAY IN BED" AND THAT PATIENT GOES THROUGH A LOT OF ICE. IT WAS STATED THAT THE PATIENT'S HUSBAND HAS TO CARE FOR HER ALL TIMES OF THE NIGHT. IT WAS STATED THAT THE FIRST TWO DAYS OF THE PATIENT'S TRIAL WERE "HORRIBLE", BUT AFTER THAT THE PATIENT HAD "PRETTY GOOD" THERAPY; THE PATIENT WAS STILL IN PAIN, BUT IT WASN¿T AS BAD AS NOW. THE TRIAL TOOK PLACE IN LATE FEBRUARY. THE PATIENT STATED THAT SHE WANTED HER IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231183 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