BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1852133 · Received September 29, 2010

    Report

    Report Number
    3004209178-2010-07417
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INTERMITTENT STIMULATION THAT BEGAN A FEW DAYS AGO. THERE WAS NO PATTERN TO INTERMITTENT STIMULATION NOTED. THE PT REPORTED THAT THERE WERE A FEW FALLS SINCE HAVING THE DEVICE IMPLANTED. HOWEVER, WHEN THE DEVICE WAS LAST CHECKED AT A REPROGRAMMING (ONE MONTH PRIOR), EVERYTHING WAS FINE. WHEN THE INS WAS CHECKED WITH THE PT PROGRAMMER, IT WAS NOTED THAT THE "LIGHTENING BOLT" ICON WAS NOT SEEN ON THE DISPLAY. THE PT DENIED BEING NEAR ANY STRONG SOURCES OF ELECTROMAGNETIC INTERFERENCE (EMI). NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR EXTENSION: MODEL 37082, LOT# NKB013160N| LEAD: MODEL 3888, LOT# V113346| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V113346| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V113346| LEAD: MODEL 3888, LOT# V113346| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013111N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE102044N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA024297N| IMPLANTED:| EXPLANTED: