BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1061480 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03243
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS EXPERIENCING STIMULATION IN THE WRONG LOCATION. FOLLOW UP WITH THE HEALTH CARE PROVIDER INDICATED THE PT'S LEVEL OF ACTIVITY WAS NOT COMPLIANT WITH POST OPERATIVE INSTRUCTIONS. PT SYMPTOMS INCLUDED SHOCKING. THE PT'S DEVICE WAS PROGRAMMED OFF FOR A FEW DAYS AND THEN RE-STARTED. THERE HAVE BEEN NO FURTHER PROBLEMS.

    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 ACCESSORY MODEL 37752| EXTENSION MODEL 37081| PROGRAMMER MODEL 37742| EXPLANTED| EXTENSION MODEL 37081| EXPLANTED