BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1872247 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07986
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    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).

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A BURNING SENSATION AT THE LOCATION OF THEIR IMPLANTED DEVICE, WHILE STIMULATION WAS TURNED ON. THE ISSUE OCCURRED FOLLOWING A FALL, AND IT WAS NOTED THE PATIENT HAD RECENT MULTIPLE FALLS. IMPEDANCE MEASUREMENTS GREATER THAN 4000 OHMS ON SOME OF THE BIPOLAR PAIRS WERE NOTED. VALUES OF 690 AND 1395 WERE REPEATED ON ALL BIPOLAR PAIRS THAT WERE NOT >4000. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT003510P| LEAD: MODEL 3998, LOT# L66471| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF012969N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF012974N