BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2831234 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10223
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748925 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID, 3888-33 LOT# J0427882V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 3550-09 LOT# LC0284, IMPLANTED: 2004 (B)(6), PRODUCT TYPE ACCESSORY; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD NO STIMULATION SENSATION. THE DEVICE HAD "QUIT WORKING." THE PATIENT HAD AN ACCIDENT 5 YEARS PRIOR BUT THE DEVICE HAD WORKED AFTERWARDS. AN IMPEDANCE CHECK WAS PERFORMED AND IMPEDANCES WERE GREATER THAN 3,000 OHMS. BATTERY VOLTAGE WAS AT 2.40 V. FOLLOW UP INFORMATION RECEIVED REPORTED THE PATIENT HAD A PLANNED BATTERY CHANGE THE DAY OF REPORT, AND THE PATIENT HAD NOT FELT STIMULATION FOR A "FEW" YEARS. SINCE IMPEDANCES WERE HIGH, THE REPLACEMENT WAS RESCHEDULED SO THE LEAD AND BATTERY COULD BE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention