BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2942736 · Received February 4, 2013

    Report

    Report Number
    6000032-2013-00030
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495LZ51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT # J0211576V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3487A, LOT # J0108145V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO TURN STIMULATION ON. IT WAS NOTED THE PATIENT TURNED THEIR STIMULATION OFF AT NIGHT BEFORE GOING TO BED. THE PATIENT TURNED THEIR STIMULATION OFF ABOUT ONE MONTH PRIOR AND WAS NOT ABLE TO TURN THE STIMULATION BACK ON. IT WAS NOTED THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE ONLY LIGHT ON THE BACK OF THE PROGRAMMER THAT WAS ON WAS THE BATTERY LIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47282 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1