BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2172368 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04761
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S STIMULATION WAS TURNING OFF. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 60 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3986A, LOT# N254944| PROGRAMMER: MODEL 37743, LOT# NKE163675N| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 273040001| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC001938V| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA151213N| IMPLANTED: