BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2931743 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01053
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399930, LOT# J0454616V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A DEVICE REPLACEMENT SURGERY. THE PATIENT FELT STIMULATION, BUT IMPEDANCES SHOWED SOME HIGH VALUES. IT WAS NOTED THAT '4-7' HAD HIGH IMPEDANCE VALUES AND THERE WAS A SUSPECTED FRACTURE/OPEN. IT WAS UNCLEAR IF THIS MEANT ELECTRODES 4 THROUGH 7 OR ELECTRODE PAIR 4 AND 7. IT WAS REPORTED THAT THE PATIENT WAS PROGRAMMED TO 'JUST 4-7' AND WAS FEELING STIMULATION. IT WAS NOTED THAT THIS WAS A GOOD SIGN THAT THE SYSTEM WAS INTACT DESPITE THE IMPEDANCES. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS ABLE TO GET GOOD COVERAGE. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37467 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention