BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2936088 · Received January 30, 2013

    Report

    Report Number
    6000032-2013-00029
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 11, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495LZ10, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7495LZ10, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-45, LOT# J0230907V, IMPLANTED: 2002-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3487A-45, LOT# J0230907V, IMPLANTED: 2002-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER INFORMATION WAS REPORTED. 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
    41418 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