BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2190758 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-05819
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 1, 2011
    Report Date
    April 6, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. ALL OF A SUDDEN, THE PATIENT LOST THERAPY. THERE WAS A FADING SENSATION IN THE RECENT PAST. IT WAS REPORTED THAT A DEVICE REPLACEMENT WAS DONE THIS MORNING TO ANOTHER DEVICE. PRIOR TO THE CHANGE-OUT, THE PATIENT FELT STIMULATION IN HIS LEG WHEN HE WAS LAID ON HIS BACK. FOR THE PAST FEW WEEKS, THE PATIENT HAD TO INCREASE STIMULATION TO FEEL STIMULATION ON HIS BACK WHEN PRESSED. THE LEAD/EXTENSION JUNCTION SITE WAS RIGHT AT THE POCKET. THE HCP DECIDED TO CHANGE OUT THE EXTENSION TO A BIFURCATED EXTENSION INSTEAD OF A POCKET ADAPTOR. THE REMOVAL WENT SMOOTHLY WITH NO COMPLICATIONS. THERE WERE NO FALLS OR TRAUMA PRIOR TO THE DEVICE CHANGE-OUT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. IMPEDANCE MEASUREMENTS WERE NORMAL. REPROGRAMMING WAS DONE AND THE PATIENT WAS NOT USING ELECTRODE 3 OR 7, PATIENT CONTINUED TO ONLY FEEL STIMULATION ON HIS MID BACK LOCATION WITH AMPLITUDE UP TO 10.5 V. IT WAS RECOMMENDED TO GET AN X-RAY OF THE INS AND EXTENSION AREA. THE PATIENT'S LEAD HAD MIGRATED DOWN FROM THE INITIAL IMPLANT SIX YEARS AGO, AND HENCE THE PATIENT LOST COVERAGE. A REVISION WAS SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU069114V.| EXTENSION: MODEL 7489, LOT# NHU100972V.| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0444336V.| LEAD: MODEL 3487A, LOT# J0455246V.| PROGRAMMER: MODEL 7435, LOT# NFT046914P.| SEE H10.| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0455246V| EXTENSION: MODEL 7489, LOT# NHU100972V| PROGRAMMER: MODEL 7435, LOT# NFT046914P| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU069114V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0444336V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: