BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 1192203 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06380
    Event Type
    Death
    Date Received
    October 7, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTABLE NEUROSTIMULATOR AND BOTH EXTENSIONS HAVE 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 IMPLANTABLE NEUROSTIMULATOR AND BOTH EXTENSIONS WERE RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO RETURN PAPERWORK. THE FUNERAL HOME WAS CONTACTED FOR THE PATIENT'S CAUSE OF DEATH; THEY WERE NOT WILLING TO DISCLOSE ANY INFORMATION REGARDING THE PATIENT'S DEATH. THE PHYSICIAN LISTED IN THE MANUFACTURER'S DEVICE TRACKING SYSTEM FOR THE PATIENT WAS CONTACTED TO TRY AND OBTAIN CAUSE OF DEATH AND DEVICE RELATIONSHIP; THE HEALTH CARE PROFESSIONAL STATED THAT THEY HAD ONLY SEEN THE PATIENT ONCE AND THAT WAS IN 2006.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7489 LOT# NHU061243V| EXTENSION MODEL 7489 LOT# NHU061233V| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 7435 LOT# NFT043793P| IMPLANTED:| LEAD MODEL 3888ES6 LOT# N27157| EXPLANTED:| IMPLANTED:| LEAD MODEL 3888ES6 LOT# N27157