BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1182183 · Received September 23, 2008

    Report

    Report Number
    3004209178-2008-06034
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 29, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A BURNING SENSATION AT THE STIMULATOR LOCATION. THE BURNING WENT AWAY WHEN THE STIMULATOR WAS TURNED OFF. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. IMPEDANCES WERE CHECKED, SOME PAIRS WERE >4000 OHMS, AND THEY REPROGRAMMED AROUND THOSE. THE PATIENT WAS AT THE CLINIC. THE PATIENT'S STATUS WAS REPORTED TO BE GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 51 YR Required Intervention EXTENSION: MODEL 7489| EXPLANTED:| LEAD: MODEL 3998| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| PROGRAMMER: MODEL 7435