BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1823567 · Received August 27, 2010

    Report

    Report Number
    3004209178-2010-06548
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 30, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(6), 2009 THAT THERE WAS A BURNING SENSATION INSIDE THE PATIENT'S POCKET WHEN THE DEVICE WAS ON. THIS HAD STARTED WITH THE PREVIOUS WEEK. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PATIENT WAS AT HOME. ON (B)(6), 2009 THE PATIENT REPORTED THAT THE DEVICE WAS REPROGRAMMED SUCCESSFULLY, THE PATIENT PROGRAMMER WAS REPLACED AND THE DEVICE WAS LOCATED IN THE BACK. HE COULD SUCCESSFULLY RECHARGE BUT WAS STILL HAVING PROBLEMS WITH THE SYSTEM. ON (B)(6), 2010 IT WAS REPORTED THAT THERE WAS AN OVERSTIMULATION SENSATION IN THE RIGHT AND LEFT LEG. THIS OCCURRED WHEN THE STIMULATION CAME ON AFTER GETTING THE DEVICE BACK UP AND CHARGED AFTER AN OVER DISCHARGE. THE PATIENT HAD BEEN UNABLE TO TURN OFF THE STIMULATION WITH THE RECHARGER OR THE PATIENT PROGRAMMER. THE PATIENT WAS AT HOME IN FAIR CONDITION. ADDITIONAL INFORMATION 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 42 YR IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N200577002| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA127102N| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB059332V| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB059333V| PROGRAMMER: MODEL 37743, LOT# NKE124632N| EXPLANTED: