BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3782600 · Received May 1, 2014

    Report

    Report Number
    3004209178-2014-08327
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7435, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7 48910, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3093-33, LOT# V266474, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-33, LOT# V260716, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION (B)(4). PMA # P970004.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT APPOINTMENT DATE MAY 6 WAS NOTED. BY THE STATEMENT: THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE, IT WAS NOTED "MAYBE" WITH A QUESTION MARK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NERVE DAMAGE IN BACK AND GETS PRICKLY FEELING DOWN LEG AND SOMETIMES STABBING PAIN IN LEG. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263614 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other