BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2101716 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03439
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PT WAS NOT ABLE TO ADJUST STIMULATION. THE PT PROGRAMMER SHOWED A POWER ON RESET MODE. THE DEVICE WAS POWERED OFF. THIS RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 H0287743

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR IMPLANTED:| LEAD: MODEL 3998, LOT# V436664| EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA140451N| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB003224V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB006057V| LEAD: MODEL 3998, LOT# V436664| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V294261027| LEAD: MODEL 3778, LOT# V189121025| PROGRAMMER: MODEL 37743, LOT# NKE149435N| IMPLANTED: