BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1944301 · Received December 6, 2010

    Report

    Report Number
    3004209178-2010-10230
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 26, 2010
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STARTED HAVING ISSUES WITH HIS DEVICE. THE PT FELT COLD. WHEN THE STIMULATION WAS ON, THE PT USUALLY FELT WARM, SO HE TURNED THE STIMULATION UP AND HE DIDN'T FEEL ANYTHING. THEN HE FELT LIKE HE WAS WARMING UP. HE HAD TURNED THE STIMULATION UP "90 CLICKS". THE PATIENT FELT STIMULATION, BUT IT FELT "TRAPPED LIKE IT WON'T RELEASE". THE PT PROGRAMMER CONFIRMED THAT THE STIMULATION WAS ON. THE PT DECREASED BOTH SIDES ALL THE WAY DOWN UNTIL HE GOT TRIPLE BEEPS; HE STILL FELT STIMULATION. THE PT WAS AT HOME. HIS STATUS WAS REPORTED TO BE "FAIR". ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 EXTENSION: MODEL 7489, LOT# NHU040532V| LEAD: MODEL 3998, LOT# J0406095V| PROGRAMMER: MODEL 7435, LOT# NFT038324P| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU040533V| IMPLANTED:| EXPLANTED: