BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3113701 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07701
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    June 13, 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
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-09, LOT# N112965, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3 587A, LOT# N0020959, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM WAS EXPLANTED ON (B)(6) 2013. IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS FAILURE OF THE DEVICE AND FAILURE TO IMPROVE PATIENT SYMPTOMS. IT WAS ALSO REPORTED THAT THE PATIENT HAD A CT SCAN ON (B)(6) 2013 WHICH HAD RESULTS OF NORMAL STRUCTURES AND STIMULATION IN THE RIGHT TEMPORAL LOBE. DURING SURGERY ON (B)(6) 2013, THERE WAS A REMOVAL OF THE ¿EXTRADURAL¿ PADDLE AND THE IMPLANTED NEUROSTIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATION SYSTEM WAS BEING EXPLANTED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD NEUROSTIMULATION SYSTEM FOR CORTICAL STIMULATION ON THE RIGHT SIDE TO CONTROL LEFT FACIAL PAIN. IT WAS FURTHER NOTED THAT THE SYSTEM WAS BEING REMOVED BECAUSE IT CAUSED PAIN AND DISCOMFORT. IT WAS NOTED THAT THE DEVICE DID NOT ALLEVIATE PAIN FOR THE PATIENT AND 'WASN'T FUNCTIONING.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214802 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