BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1231033 · Received October 30, 2008

    Report

    Report Number
    3004209178-2008-07058
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, NO STIMULATION AND A SHOCKING OR JOLTING SENSATION IN 2008. AT THE TIME OF THE REPORT, THE PATIENT WAS AT HOME IN GOOD CONDITION. THE PATIENT WAS REDIRECTED TO CONTACT THE PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 40 YR PROGRAMMER: MODEL 37742| EXPLANTED:| EXTENSION: MODEL 37083| EXPLANTED:| LEAD: MODEL 3487A| IMPLANTED:| IMPLANTED: