BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2183663 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05259
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    January 1, 2010
    Report Date
    June 15, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON AND OFF SHOCKING AND SORENESS OCCURRED AT THE INS POCKET. PT WOULD KEEP LOG WHEN THEY EXPERIENCE SHOCKING AT POCKET AND WHAT POSITION THEY WERE IN. THE SYMPTOMS OF THE EVENT OCCURRED ABOUT 1.5 YEARS AGO. NO FALLS OR TRAUMAS HAVE OCCURRED BUT PT HAD KNEE SURGERY SINCE IMPLANT. THERE WAS A POSSIBLE CORRELATION OF SHOCKING WITH ACTIVITY OF RIGHT LEG. IT WAS REPORTED THAT WHEN PT PRESSES ON INS THEY CAN'T CREATE SHOCKING FEELING BUT IF THEY USE RIGHT LEG AND PALPATE THEY CAN CREATE SHOCKING SENSATION. IT WAS REPORTED THAT THERE WERE IMPEDANCE READINGS >10000 OHMS. 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 61 YR LEAD: MODEL 3777, LOT #V051856002| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #NKE102983N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT #V074875030| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA111753N| IMPLANTED:| EXPLANTED:| IMPLANTED: