BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 1222164 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07238
    Event Type
    Death
    Date Received
    November 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE CORONER REPORTED A PATIENT DEATH. ALL INFORMATION WAS PENDING AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 3004209178-2008-07237.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death IMPLANTED:| LEAD: MODEL| PROGRAMMER: MODEL 7435| IMPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888| EXPLANTED:| IMPLANTED:| NFE407691H| IMPLANTABLE NEURO STIMULATOR: MODEL 7427V| EXTENSION: MODEL 7489| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| EXPLANTED: