BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1890207 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08280
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 27, 2010
    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
    MA, 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 A SHOCKING OR JOLTING SENSATION AT THE LEAD SITE. THIS SENSATION BEGAN AFTER THE PT BENT OVER TO PICK UP SOMETHING. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. IT WAS STATED THAT BOTH PT MOVEMENT AND PALPATION OF THE SITE, RESULTED IN A CHANGE IN STIMULATION. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR LEAD: MODEL 3778, LOT # V075289001| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB008614N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT # V042634| EXPLANTED:| LEAD: MODEL 3888, LOT # V010351| ACCESSORY: MODEL 37752, LOT # NKA016376N| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD017611N