BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1231230 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07414
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION WAS 'JUST NOT RIGHT', FOLLOWING SOME FORM OF TRAUMA. THE DETAILS OF THE TRAUMA ARE UNK. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 68 YR EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| EXTENSION: MODEL 37081| LEAD: MODEL 39565| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: