BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4220740 · Received November 3, 2014

    Report

    Report Number
    6000032-2014-00255
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 17, 2002
    Report Date
    October 13, 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: PRODUCT ID 7495LZ10, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 7495LZ10, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3487A, LOT# J0225562V, IMPLANTED: 2002-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3888-28, LOT# J0225498V, IMPLANTED: 2002-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS REPLACED IN MAY WAS NOT REPLACED DUE TO NORMAL BATTERY DEPLETION BUT REPLACED BECAUSE IT HAD NOT WORKED RIGHT SINCE IMPLANT. THE PATIENT WAS UNABLE TO SAY WHAT WAS NOT WORKING ONLY THAT IT HAD TO BE REPLACED BECAUSE ¿IT¿ WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701245 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention