BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2113802 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03591
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION WITH THE PATIENT PROGRAMMER. THE PROGRAMMER'S DISPLAY SHOWED A "CALL YOUR DOCTOR" ICON. A POWER ON RESET (POR) CONDITION WAS ENCOUNTERED. CLEARING THE POR WITH THE NAVIGATION KEY RESOLVED THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXPLANTED:| LEAD: MODEL 3888, LOT# V175501| EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# N246783| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N188060| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA139923N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE148285N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC008532N