BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1182846 · Received September 25, 2008

    Report

    Report Number
    3004209178-2008-06127
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 26, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED WORSENING PAIN IN THE NEUROSTIMULATOR POCKET SITE SINCE IMPLANT. THE PAIN HAD ALWAYS BEEN PRESENT BUT WAS SLOWLY GETTING WORSE. THE HEALTH CARE PROFESSIONAL (HCP) RECOMMENDED THE PATIENT TO SLEEP ON HER SIDE TO ALLEVIATE THE PRESSURE ON THE NEUROSTIMULATOR. THE PATIENT COMPLAINED TO THE PHYSICIAN ABOUT LACK OF EFFECT, NEW PAIN AT THE NEUROSTIMULATOR SITE AND SHOCKING SENSATION. DURING EVALUATION THE HCP FOUND INCREASED IMPEDANCE IN MULTIPLE ELECTRODES. AN X-RAY EVALUATION PROVIDED NO ADDITIONAL INFORMATION. THE PATIENT WAS REFERRED FOR REVISION/REPLACEMENT SURGERY FOR BROKEN LEAD/EXTENSION. NO PATIENT INJURY WAS REPORTED.

    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 81 YR Required Intervention EXTENSION: MODEL 7489| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| LEAD: MODEL 3998| PROGRAMMER: MODEL 7435| EXPLANTED:| IMPLANTED: