BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1926031 · Received November 10, 2010

    Report

    Report Number
    3004209178-2010-09239
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 25, 2010
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS UNABLE TO ADJUST HER STIMULATION AND HAD COMMUNICATION AND COUPLING ISSUES WITH HER IMPLANTABLE NEUROSTIMULATOR. ABOUT TWO WEEKS LATER, SHE MET WITH HER HEALTH CARE PROFESSIONAL. THE HCP STATED, SHE "NEEDS TO GET STIM FIXED" AND "NEEDS TO GET BATTERY REPLACED." NO PATIENT SYMPTOMS WERE REPORTED. 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 39 YR PROGRAMMER: MODEL 37743, LOT# NKE113177N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB045479V| EXTENSION: MODEL 37081, LOT# NJB045576V| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N170223004| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA115974N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: