BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1123868 · Received August 15, 2008

    Report

    Report Number
    9614453-2008-05002
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEUROSTIMULATOR AND EXTENSION WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED HIGH AMPLITUDE WAS REQUIRED AT THE INITIAL PROGRAMMING SESSION IN 2007. THE PATIENT RECEIVED SATISFACTORY COVERAGE. IMPEDANCE READINGS WERE SATISFACTORY INITIALLY. DURING A SECOND CHECK OF IMPEDANCE READINGS, IMPEDANCES CHANGED TO > 4000 OHMS USING A COMBINATION OF ELECTRODE 1 AND 3. ALL OTHER READINGS WERE WITHIN NORMAL LIMITS. THE DEVICE WAS REVIEWED ONE MONTH LATER. THE SAME SETTINGS WERE USED. THE NEUROSTIMULATOR SHOWED 45-90% USED. IMPEDANCE READINGS WERE >4000 OHMS ON CONTACTS 1 AND 3. OTHER READINGS WERE WITHIN NORMAL LIMITS. THE DEVICE WAS REVIEWED TWO MONTHS LATER. THE NEUROSTIMULATOR READING SHOWED 70-90% USED. IMPEDANCES WERE WITHIN NORMAL LIMITS ON ALL COMBINATIONS. THE DEVICE WAS REVIEWED AGAIN. THE FOLLOWING YEAR, THE NEUROSTIMULATOR BATTERY READING WAS LOW AND DEFAULTED TO FACTORY SETTINGS. THE PATIENT EXPERIENCED A LOSS OF EFFECT. THE PATIENT WAS ADDED TO A WAITING LIST FOR NEUROSTIMULATOR REPLACEMENT. THE PATIENT IS ELDERLY. THE PATIENT UNDERWENT GENERAL ANESTHETIC DUE TO NEUROSTIMULATOR FAULT. THE NEUROSTIMULATOR WAS EXPLANTED. IT WAS REPORTED THE PATIENT HAD AN INFECTION. REFER TO MANUFACTURER REPORT 9614453-2008-04998 FOR DETAILS ABOUT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC SWISS MANUFACTURING FACILITY 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANTED:| EXTENSION: MODEL 7489| IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK| EXPLANTED: