BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2871576 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11782
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS BEING USED OFF-LABEL. THE THERAPY IT WAS USED FOR WAS CODE EZW--URINARY. PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-28, LOT# J0424924V, IMPLANTED: 2004 (B)(4), PRODUCT TYPE LEAD, PRODUCT ID 3889-28, LOT# J0546512V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER DEVICE REMOVED IN "LATE JULY/EARLY AUGUST." THE INCISION THAT WAS MADE TO REMOVE THE DEVICE BECAME INFECTED. THE PATIENT STATED THAT THE INFECTION WAS TREATED AND HAD HEALED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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