BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2193301 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05399
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS REPORTED THAT THERE WAS A "CALL YOUR DOCTOR" ICON AND A POR CONDITION. 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 MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR LEAD: MODEL 3777, LOT #V128485005| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, NOT #NKA116323N| PROGRAMMER: MODEL 37743, LOT #NKE115697N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT #V156540006| IMPLANTED: