BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2877857 · Received December 18, 2012

    Report

    Report Number
    3004209178-2012-11979
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Report Date
    November 28, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N231804, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO STIMULATION SENSATION. THE REPORTER STATED THAT THIS HAD HAPPENED BEFORE AND THEY 'REWIRED THROUGH OTHER WIRES' BUT NOW IT WASN'T WORKING AT ALL. IT WAS UNCLEAR WHAT WAS MEANT BY 'REWIRED THROUGH OTHER WIRES.' THE PATIENT WAS AT WORK WHEN THIS OCCURRED AND DID NOT HAVE HIS PATIENT PROGRAMMER OR RECHARGER. IT WAS REPORTED THAT THE STIMULATION WOULDN'T GO UP OR DOWN OR COME ON. IT WAS NOTED THAT THE PATIENT'S RECHARGER WORKED AND THE DEVICE WAS FULLY CHARGED. THE PATIENT STATED THAT HE THOUGHT IT WAS THE WIRES BECAUSE HE HAD BROKEN TWO WIRES BEFORE. THE REPORTER STATED THAT THE PATIENT COULD TURN THE DEVICE ON AND OFF WITH THE RECHARGER BUT HE 'DIDN'T TURN IT OFF, IT JUST QUIT WORKING.' IT WAS REPORTED THAT THE PATIENT COULDN'T TURN THE DEVICE ON OR OFF WITH THE RECHARGER OR PATIENT PROGRAMMER, BUT WAS ABLE TO BEFORE. IT WAS UNCLEAR IF THE DEVICE COULD BE TURNED OFF WITH THE RECHARGER OR NOT. THE PATIENT DIDN'T RECALL IF STIMULATION WAS ON OR OFF THE LAST TIME HE SYNCED THE DEVICE WITH THE PATIENT PROGRAMMER OR RECHARGER. IT WAS REPORTED THAT THE PROBLEM OCCURRED ON THE DAY OF THE REPORT. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN HAVING PROBLEMS WITH IT FOR A MONTH OR SO, 'GOING OFF THE WALL, TURNING OFF AND ON.' IT WAS UNCLEAR IF 'IT' REFERRED TO THE DEVICE OR THE PATIENT PROGRAMMER, AND IT WAS UNCLEAR HOW LONG THE PATIENT HAD PROBLEMS. IT WAS NOTED THAT THE PATIENT WANTED A DIAGNOSTIC TEST DONE ON THE STIMULATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1