BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2251185 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07564
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CYCLING AND SHOCKING OVERSTIMULATION SENSATION "FOR A MOMENT," WHILE WALKING. THE PATIENT ALSO EXPERIENCED AN INCREASE IN PAIN, WITH "DIFFERENT PAIN PATTERNS," ABOUT ONE MONTH AGO FOLLOWING SOME STRENUOUS ACTIVITY. AT THE END OF THE DAY, THE PATIENT HAD URINARY INCONTINENCE WITH URGENCY AND FREQUENCY. IT WAS LATER REPORTED THAT WHILE THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON, THE PATIENT CHANGED POSITION AND THEN FELT AS THOUGH THE DEVICE TURNED OFF RESULTING IN AN INCREASE IN PAIN. THIS BEGAN ONE WEEK AGO. THE PATIENT DENIED THE OCCURRENCE OF ANY FALLS. IT WAS FURTHER REPORTED THAT THE NEUROSTIMULATOR TURNED ON AND OFF WHILE THE PATIENT WAS WALKING. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PROGRAMMER: MODEL 7435, LOT# NFT003460P| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0069868N| EXTENSION: MODEL 7495-51, LOT# XR0069867N| EXPLANTED:| EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA026075N| EXPLANTED:| LEAD: MODEL 3998, LOT# L74873| IMPLANTED: