BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2260038 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06956
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A POWER ON RESET (POR) CONDITION ON THEIR NEUROSTIMULATOR. IT WAS NOTED THAT THE PT WAS AROUND AN ELECTRICAL STORM ON FRIDAY NIGHT. THE PT WAS ABLE TO CLEAR THE POR CONDITION HERSELF AND REGAINED HER STIMULATION. IT WAS ALSO NOTED THAT SHE WAS ABLE TO RECHARGE NORMALLY. ADDITIONALLY INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. 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 57 YR EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA148348N| PROGRAMMER: MODEL 37743, LOT# NKE159763N 0| LEAD: MODEL 39565-65, LOT# V574040002| IMPLANTED: