BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1140907 · Received August 28, 2008

    Report

    Report Number
    3004209178-2008-05294
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 30, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION; "WHEN USING PROGRAM FOR LOW BACK GETS PAINFUL ABDOMINAL AREA". THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE REPORT. THE PATIENT WAS AT HOME. THE PATIENT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3777| IMPLANTED:| ACCESSORY: MODEL 37752| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777| PROGRAMMER: MODEL 37743