BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3092449 · Received May 3, 2013

    Report

    Report Number
    6000032-2013-00112
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A, LOT# L55108, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE TIME OF REPORT THE DEVICE WAS "NOT WORKING" AND THE PATIENT WAS WAITING TO HAVE THE BATTERY REPLACED. IT WAS NOTED THE PATIENT HAD THE DEVICE OFF FOR "QUITE A WHILE" DUE TO HAVING BEEN SICK. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194046 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1