BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2102620 · Received May 23, 2011

    Report

    Report Number
    3004209178-2011-03739
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 26, 2011
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD A FLARE UP WITH PAIN A MONTH AND A HALF AGO. HE INCREASED THE STIMULATION AND IT HELPED. ON (B)(6) 2011, PT STARTED NOT BEING ABLE TO FEEL THE STIMULATION. IN THE BACK OF HIS UPPER THIGH, HE IS FEELING CATCHING OR CRAMPING. THE ISSUE WITH THE THIGHS STARTED A MONTH AGO. HE SAID WHEN HE IS LYING DOWN HE IS FINE. BUT WHEN HE STANDS UP, HE HAS TO GO SLOWLY. HE HAS A HARD TIME STANDING UP. PT HAD NOT HAD ANY FALLS, ACCIDENTS, OR MEDICAL PROCEDURES. THE PT WAS AT HOME WITH A REPORTED STATUS OF FAIR.

    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 57 YR EXTENSION: MODEL 7495-25, LOT# NAF000257V| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0102006V| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0102007V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF000258V| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT070705P| EXPLANTED:| IMPLANTED:| IMPLANTED: