BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1191864 · Received October 1, 2008

    Report

    Report Number
    3004209178-2008-06269
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY FOUND. THE DEVICE WAS FUNCTIONALLY OK. LEAD: 3891, EXTENSION: MODEL 7489. THE LEAD AND EXTENSIONS WERE OK, BUT CUT THROUGH SUSPECTED EXPLANT DAMAGE. FINAL DEVICE ANALYSIS REVEALED 'NO ANOMALY FOUND'.

    Description of Event or Problem · 1

    THE DEVICE SYSTEM WAS RETURNED TO THE MFR WITH NO CLINICAL INFO. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 23 YR EXPLANTED:| EXTENSION: MODEL 7489| STIM ACCESSORY: MODEL TITAN ANCHR| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| LEAD: MODEL 3891| IMPLANTED:| STIM ACCESSORY: MODEL TITAN ANCHR| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3891| EXPLANTED: