BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4200308 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20354
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 4, 2014
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LOWER BACK WAS OUT AND THEY HAD A PRE-EXISTING CONDITION WITH THEIR CERVICAL SPINE. THE PATIENT WAS IN PAIN AND HAD X-RAYS A MONTH PRIOR, BUT THE RESULTS WERE NOT AVAILABLE AT THE TIME OF THE REPORT. A COUPLE WEEKS AFTER THE X-RAY, THE PATIENT SAW A POWER ON RESET (POR) MESSAGE ON THEIR RECHARGER AFTER HAVING A CT SCAN. THE PATIENT WAS UNABLE TO CHARGE THEIR DEVICE SINCE THE DATE OF THE CT SCAN. IT WAS REPORTED THAT THE PATIENT FAILED TO TURN THEIR DEVICE OFF PRIOR TO THE X-RAY AND IT RESULTED IN A POR. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO CLEAR THE POR, AND THE STIMULATION WAS WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679578 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 00054 YR