BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3184941 · Received June 24, 2013

    Report

    Report Number
    3004209178-2013-10751
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3778-75 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-29 LOT# N153073, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37752 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEING THE POOR COMMUNICATION SCREEN FOR THE TWO NIGHTS PRIOR TO THIS REPORT. IT WAS NOTED BATTERIES WERE CHANGED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN CHARGED THE DAY PRIOR TO THIS REPORT. IT WAS NOTED PATIENT ADJUSTED ANTENNA CORD AND WAS NOW SEEING REGULAR PROGRAMMING SCREEN AND THE PROGRAMMER WAS WORKING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT FEELING STIMULATION THE SAME WAY THEY WERE PREVIOUSLY. IT WAS NOTED PATIENT DOES NOT FEEL STIMULATION HOWEVER, SOMETIMES IT CAME ON RANDOMLY. IT WAS NOTED THIS STARTED ABOUT A WEEK PRIOR TO THIS REPORT AND HAS PROGRESSIVELY GOTTEN WORSE. STIMULATION WAS USUALLY FELT AT 1.8 OR 1.9, BUT AT 3.3 WAS STILL NOT FEELING STIMULATION. PATIENT DID HAVE A FALL ABOUT A MONTH PRIOR TO THIS REPORT, PATIENT HAD FALLEN ON THEIR HIP WITH THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT THE PATIENT HAD RECEIVED ASSISTANCE AND THEIR CONCERNS WERE RESOLVED ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285162 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 00066 YR