BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1926380 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09258
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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 THE PT EXPERIENCED NO STIMULATION SENSATION AND THAT MOVEMENT CAUSED STIMULATION CHANGES. THERE WAS NO RELATED ACCIDENT OR INCIDENT. IMPEDANCE LEVELS WERE >10,000 OHMS. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V384064022| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE143510N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA135409N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V384062001