BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3840473 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09870
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2012
    Report Date
    August 24, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A-33, LOT# J0454723V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR HAD NOT BEEN WORKING PROPERLY FOR THE PATIENT FOR 2 YEARS. IT WAS NOTED THAT THE PATIENT NEEDED TO KNOW WHAT TO DO TO HAVE HER DEVICE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY WANTED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED BECAUSE IT DIDN¿T WORK PROPERLY. THE CONSUMER FURTHER CLARIFIED THIS TO MEAN SOMETIMES THEY WOULD FEEL STIMULATION IN THEIR LEG, AND OTHER TIMES THEY COULDN¿T. IT WAS NOTED THE CONSUMER WOULD TURN THE INS ON AND ¿IT DIDN¿T DO ANYTHING¿ AND THEY WOULD BE ABLE TO LEAVE IT ON FOR TWO TO THREE HOURS, AND THEN THEY WOULD FEEL STIMULATION. THE CONSUMER DIDN¿T KNOW WHAT WAS CAUSING THEM TO FEEL STIMULATION INTERMITTENTLY, AND WONDERED IF IT WAS THAT THE LEADS WEREN¿T CONNECTED PROPERLY SINCE ¿IT ONLY WORKED WHEN IT WANTED TO.¿ IT WAS NOTED THE CONSUMER DIDN¿T CURRENTLY HAVE A DOCTOR, HADN¿T SEEN ONE IN FOUR YEARS, AND WAS LOOKING FOR A DOCTOR TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319214 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR