BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1915548 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08942
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. PT STATED, SHE ONLY FELT THE VIBRATIONS IN HER CALVES TO THIGHS. THIS STARTED ON (B)(6) 2010 AND PRIOR TO THAT SHE WAS GETTING BETTER COVERAGE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PT WAS AT HOME. THE PT WAS NOT BEING ABLE TO ADJUST STIMULATION. THE DISPLAY SHOWED THE "CALL YOUR DR" ICON. THE PT WAS THEN ABLE TO SUCCESSFULLY COMMUNICATE WITH HER IMPLANTABLE NEUROSTIMULATOR (INS). THERE WERE NOT ANY ERROR CODE/NUMBER ASSOCIATED WITH THE CALL YOUR DR MESSAGE. THE STIMULATION WAS ON AND SET AT 2.3. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 74 YR EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 244080002| EXTENSION: MODEL 37081, LOT# NJB038058V| IMPLANTED:| LEAD: MODEL 3777, LOT# V146552002| ACCESSORY: MODEL 37752, LOT# NKA139185N| PROGRAMMER: MODEL 37743, LOT# NKE148003N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: