BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3142280 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08520
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿IN THE BOX¿ ICON WAS DISPLAYED AND THE PATIENT COULD NOT ADJUST STIMULATION. IT WAS NOTED THAT THE PATIENT HAD BEEN SEEING THE ICON SINCE (B)(6) 2013. IT WAS NOTED THAT THE SCREEN NEEDED TO BE CLEARED WITH A CLINICIAN PROGRAMMER AND THAT SENDING THE PATIENT A NEW PROGRAMMER WILL NOT SOLVE THE ISSUE. IT WAS REPORTED THE PATIENT DID NOT USE THE ANTENNA LOCATE (AL) FEATURE OFTEN. IT WAS ALSO NOTED THAT THE PATIENT WAS ABLE TO TURN STIMULATION ON AND OFF WITH HER CHARGER AND IT WAS AT A COMFORTABLE LEVEL AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR AND/OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243351 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 00035 YR