BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3810260 · Received May 14, 2014

    Report

    Report Number
    6000032-2014-00094
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# L87361, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTERNAL NEUROSTIMULATOR (INS) DID NOT LAST MORE THAN FOUR OR FIVE MONTHS. IT WAS NOTED THE INS WAS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288353 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR