BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3163492 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10179
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 21, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN ON THE RIGHT SIDE OF BACK. THE CAUSE OF THE EVENT WS UNKNOWN. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013 AND GOT GOOD STIMULATION/PAIN RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED 2 WEEKS AGO, THAT THE PATIENT WORKED TOO MUCH OUTSIDE AND EVERY ¿JOINT IN HER BACK WAS SWOLLEN.¿ IT WAS STATED THAT THE PROBE (INTERPRETED AS LEAD) SHIFTED A TAB BIT. IT WAS ADDED THAT WHEN THE PATIENT SAT, SHE FELT ¿INTENSE MOTIONS¿ ON THE RIGHT SIDE OF HER BACK. IT WAS ALSO STATED THAT WHILE WALKING, THE PATIENT COULD NOT FEEL STIMULATION ON PROGRAMS 1 AND 2, EVEN AFTER INCREASING AMPLITUDE TO OVER 2 VOLTS. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE RECENTLY TURNED OFF PROGRAMS 3 AND 4. IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT ADJUST STIMULATION. IT WAS STATED THAT THERE WAS A ¿CALL YOUR DOCTOR¿ ICON AND AN O UT-OF-REGULATION (OOR) CONDITION. IT WAS ALSO STATED THAT THE OOR WAS FIRST SEEN YESTERDAY. THE PATIENT REPORTEDLY WENT TO SEE HER HEALTHCARE PROVIDER (HCP) TODAY AND WAS TOLD TO CALL THE MANUFACTURER. IT WAS NOTED THAT THE PATIENT NO LONGER HAD A MANAGING HCP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT "IT WOULD TAKE LIKE ABOUT 15 MINUTES FOR ME TO BE ABLE TO TURN THE STIMULATOR ON OR TURN IT OFF." IT WAS NOTED THAT THIS HAPPENED WITHIN THE TWO WEEKS WHEN THE PATIENT WAS SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264352 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 00050 YR