BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2182182 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05195
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    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 COUPLING AND OR COMMUNICATION ISSUES. THE DEVICE WAS FLIPPED. AFTER USING THE ANTENNA LOCATOR AND TRYING TO RECHARGE MULTIPLE TIMES, THE HCP ELECTED TO NOT PERFORM X-RAYS AND TO JUST FLIP THE IPG. AFTER DOING SO, 8 BARS IMMEDIATELY SHOWED UP ON THE PT'S RECHARGER. THE PT WAS CURRENTLY DOING FINE, BUT WAS SCHEDULED TO HAVE HIS BATTERY MOVED TO A DIFFERENT LOCATION. AFTER SURGERY FROM MOVING THE BATTERY, THE PT RECOVERED AND WAS RECEIVING SATISFACTORY STIMULATION. 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 66 YR EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE162192N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V623333002| LEAD: MODEL 3778, LOT# V623333003| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA149150N