BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2934818 · Received January 30, 2013

    Report

    Report Number
    6000032-2013-00027
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 7495-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3487A-45, LOT # J0120760V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # J0120760V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S STIMULATION "HAS NOT WORKED SINCE 8 MONTHS AFTER IT WAS IMPLANTED." NO FURTHER INFORMATION ABOUT THE EVENT WAS REPORTED. IF MORE INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HIS DEVICE OR THERAPY AND WAS WORKING WITH HIS HEALTHCARE PROFESSIONAL OR MANUFACTURER REPRESENTATIVE. NO APPOINTMENT DATES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40981 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG. 7427

    Patients

    Seq Age Sex Outcome Treatment
    1