BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2963843 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02714
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 28, 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

    PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NO CONCERNS REGARDING HER DEVICE OR THERAPY, AS WELL AS THE PATIENT HAD RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT HAD MET WITH THE REPRESENTATIVE ELEVEN DAYS EARLIER AND HAD NO FURTHER CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "SHARP" PAIN IN HER LOW BACK "ABOUT A WEEK" PRIOR TO DATE OF THIS REPORT. PATIENT DENIED ANY RECENT FALLS OR TRAUMA. THE PATIENT WAS REPORTEDLY "VERY SICK." IT WAS STATED THAT AFTER BEING SICK ON (B)(6) 2013, THE PATIENT INCREASED HER STIMULATION. IT WAS STATED THAT THE PATIENT EXPERIENCED A "SHARP SHOCKING PAIN" IN HER LOWER BACK FOUR OR FIVE DAYS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PAIN WAS "VERY BAD" AND SHE GOT IT "ABOUT 100 TIMES A DAY." THE PATIENT REPORTEDLY LOWERED HER STIMULATION THE DAY PRIOR TO THE REPORT AND HER BACK PAIN WAS "A LITTLE BETTER." A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67045 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