BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3191589 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10949
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 8, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING ISSUES WITH THE STIMULATION "SPUTTERING" WHEN HE CHANGED POSITIONS OR CROSSED HIS LEGS. IT WAS NOTED THAT THE STIMULATION WAS ¿THAT SENSITIVE¿ AND THE STIMULATION WOULD START TO SPUTTER. IT WAS NOTED THAT THIS STARTED TO HAPPEN TWO DAYS PRIOR TO REPORT. IT WAS FURTHER NOTED THAT THE FIRST SPUTTERING EVENT OCCURRED THURSDAY NIGHT AND THAT HE DID NOT NOTICE ANOTHER EVENT UNTIL FRIDAY AFTERNOON AT 4 P.M. IT WAS NOTED THAT THE PATIENT TURNED ON HIS STIMULATION ON THE MORNING OF REPORT FOR THREE MINUTES AND CROSSED HIS LEGS AND IT STARTED SPUTTERING. THERE WERE NO KNOWN ACCIDENTS OR INCIDENTS RELATED TO THIS EVENT. IT WAS FURTHER NOTED THAT THE PATIENT WALKED THE DOG NORMALLY AND CUT HIS GRASS BUT HAD LIMITED ACTIVITIES AND HAD NOT HAD ANYTHING GOING ON OUT OF THE ORDINARY. IT WAS NOTED THAT WHEN THE PATIENT COUGHED AND SNEEZED HE WOULD GET A ¿SURGING¿ AND HAD ALWAYS EXPERIENCED THAT, BUT FELT IT WAS NORMAL FROM THE VIBRATION OF THE STIMULATION. IT WAS NOTED THAT THE PATIENT STATED THAT HE HAD NOT EXPERIENCED ANYTHING OF THAT NATURE AND HAD BEEN GETTING NERVOUS. IT WAS FURTHER NOTED THAT THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR PAIN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS NOTED AS CHANGES IN POSITION RESULTED IN INTERMITTENT FUNCTIONING. REPROGRAMMING WAS PERFORMED BETWEEN (B)(6) 2013. THE PATIENT NOTED ON (B)(6) 2013 THAT THE STIMULATOR WAS REPROGRAMMED AND THE PATIENT WAS HAPPY WITH THE OUTCOME. SIGNS AND SYMPTOMS INCLUDED SPUTTERING WHEN POSITIONAL CHANGE. HOSPITALIZATION WAS NOT REQUIRED. PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290155 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 00053 YR