BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2040850 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-02196
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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, THERE WAS A POWER ON RESET (POR) CONDITION, AND THE STIMULATION COULD NOT BE ADJUSTED WITH THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 54 YR ACCESSORY: MODEL 37752, LOT# NKA113126N| IMPLANTED:| LEAD: MODEL 3998, LOT# LA2419| EXTENSION: MODEL 37082, LOT# NKB013075N| PROGRAMMER: MODEL 37743, LOT# NKE107530N| EXPLANTED:| EXPLANTED:| IMPLANTED: