BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2851622 · Received November 29, 2012

    Report

    Report Number
    6000032-2012-00209
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # LB6465, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT # J0235384V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER ON RESET (POR) CONDITION. IT WAS STATED THAT THE PARAMETERS AND SERIAL NUMBER HAD TO BE REENTERED. IT WAS NOTED THAT NO ERROR CODE WAS ASSOCIATED WITH THE POR. IT WAS LATER REPORTED THAT THE POR WAS CLEARED, ALTHOUGH THE CAUSE WAS NOT DETERMINED. IT WAS STATED THAT THE STIMULATION WAS RESTORED, ALTHOUGH THE PATIENT HAD "EXTREME" SENSITIVITY TO POSTURAL CHANGE. IT WAS NOTED THAT AN IMPEDANCE CHECK REVEALED THAT ONE ELECTRODE WAS OUT OF RANGE, WHICH WAS "MADE SURE NOT TO USE." THE BATTERY CHECK REVEALED STATUS WAS "OK." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1