BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2011487 · Received March 7, 2011

    Report

    Report Number
    9614453-2011-01700
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    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

    (B)(4): FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE BATTERY WAS DEPLETED AND WAS REPLACED. THE PHYSICIAN FELT THERE WAS A POTENTIAL FAILURE AND RETURNED THE DEVICE TO THE MANUFACTURER FOR ANALYSIS. THE PATIENT WAS DOING WELL POST-REPLACEMENT. THE PROGRAM SETTINGS WERE AS FOLLOWS: PROGRAM 1: LOWER LIMIT 2.0V; UPPER LIMIT 5.6V; PULSE WIDTH: 270MCS; 130HZ; ELECTRODE 0+, ELECTRODE 2-. PROGRAM 2: LOWER LIMIT 2.0V; UPPER LIMIT 5.7V; PULSE WIDTH: 300MCS; 130HZ; ELECTRODE 1-, ELECTRODE 3+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC EUROPE SARL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention