BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1191848 · Received October 1, 2008

    Report

    Report Number
    3004209178-2008-06267
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR MALPOSITION OR MIGRATION.

    Description of Event or Problem · 1

    THE PT EXPERIENCED STIMULATION SENSATION IN THE WRONG LOCATION. THE HCP WAS UNABLE TO REPROGRAM HER DEVICE TO COVER HER LEFT SIDE WHERE SHE HAD NO STIMULATION COVERAGE. AN X-RAY REVEALED THAT THE LEAD WAS TILTED (DATE NOT REPORTED). THE PT HAD AN APPOINTMENT SCHEDULED WITH HER HCP. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L 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 63 YR EXPLANTED:| LOT # NKF704830H| EXTENSION: MODEL 37081| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777| LEAD: MODEL 3777| IMPLANTED:| LEAD: MODEL 39565| EXPLANTED: