BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 6358093 · Received February 24, 2017

    Report

    Report Number
    3004209178-2017-04575
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    September 1, 2006
    Report Date
    February 24, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 399945, LOT# V003286, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR DEVICE WAS REMOVED JUST A FEW MONTHS AFTER IT WAS IMPLANTED DIE TO NERVE DAMAGE, AND ALLERGY TO TITANIUM LEADS. THE PATIENT WAS IMPLANTED FOR MULTIPLE BACK OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140005 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention