BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3073552 · Received April 23, 2013

    Report

    Report Number
    6000032-2013-00102
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT # L80903, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE DIED ABOUT THREE YEARS AGO IN 2010. THE REPORTER STATED THAT THE DEVICE WAS GOING TO BE REMOVED AS THE PATIENT HAD TO HAVE SOME MRIS DUE TO A NEW INJURY IN HER BACK. IT WAS NOTED THAT THE BACK INJURY WAS NOT RELATED TO THE DEVICE. 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
    175325 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention