BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1854167 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07456
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT EXPERIENCED A LOSS OF ALL STIMULATION SENSATION. THE PT HAD FELT STIMULATION YESTERDAY ((B)(6) 2010) AND HAD RECHARGED THE IMPLANTED DEVICE BATTERY OVERNIGHT. THE NEXT MORNING WAS WHEN THE LOSS OF STIMULATION WAS EXPERIENCED. THE PT CONFIRMED THE DEVICE WAS ON (SEEING LIGHTING BOLT ICON). AMPLITUDE WAS NOTED AS BEING 5.9, WHICH WAS THE TYPICAL SETTING. THE PT HAD CHANGED THE BATTERIES, AND INCREASED STIMULATION FROM 5.9 VOLTS TO 6.4 VOLTS AND STILL DID NOT FEEL ANY STIMULATION. IT WAS INDICATED THAT THERE WAS NO KNOWN INCIDENT OR ACCIDENT THAT COULD BE RELATED TO THE ISSUES. THE PT WAS, HOWEVER, NOTED AS RECOVERING FROM CHEMOTHERAPY, AND WAS INTENDING ON FINDING A LOCAL COMPANY REP FOR HELP WITH REPROGRAMMING HER DEVICE. THE OUTCOME OF THE PT WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 63 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE112713N| ACCESSORY: MODEL 37752, LOT# NKA115915N| IMPLANTED:| LEAD: MODEL 3487A, LOT# L48290| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC007742N| STIM ACCESSORY: MODEL 3550-29, LOT# N139695| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: