BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1812492 · Received August 16, 2010

    Report

    Report Number
    3007566237-2010-06152
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    January 29, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A PATIENT'S LEADS WERE EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE READINGS, AND A LOSS OF THERAPEUTIC EFFECT. A LEAD FRACTURE WAS INITIALLY SUSPECTED. THE NEUROSTIMULATOR DEVICE WAS EXPLANTED DUE TO THE BATTERY BEING NEAR ITS SUSPECTED END OF LIFE. THE EXTENSIONS COULD NOT BE ADAPTED, SO THEY WERE REPLACED ALSO. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC NEUROMODULATION 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXTENSION: MODEL 7489, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3587A, LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# UNK| LEAD: MODEL 3587A, LOT# UNK| EXPLANTED: