BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3810390 · Received May 14, 2014

    Report

    Report Number
    6000032-2014-00096
    Event Type
    Injury
    Date Received
    May 14, 2014
    Report Date
    April 24, 2014
    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
    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 PATIENT¿S INTERNAL NEUROSTIMULATOR (INS) DID NOT LAST. IT WAS NOTED THE INS DID NOT LAST MORE THAN FIVE OR SIX MONTHS. IT WAS REPORTED THE PATIENT DID NOT GET THEM REPLACED RIGHT AWAY DUE TO NOT BEING FULLY HEALED FROM THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288835 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention