BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1140625 · Received August 28, 2008

    Report

    Report Number
    3004209178-2008-05308
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE STIMULATION IS TURNED ON, A SHOCKING OR JOLTING SENSATION OCCURS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PATIENT BEGAN FEELING THIS LAST THURSDAY (JULY 24) WHEN HE TRIED TO TURN HIS NEUROSTIM ON. HE IS FEELING THE STIM UP AND DOWN HIS BACK. THE PATIENT WAS AT HOME. THE PATIENT WAS REDIRECTED TO HIS PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD MODEL 3777 LOT# V072243001| PROGARMMER MODEL 37742 LOT# NJD061683N