BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1111560 · Received August 13, 2008

    Report

    Report Number
    9614453-2008-04915
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    February 13, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. ELECTRICAL CONNECTIONS WERE INTACT FOR BOTH TERMINALS. THERE WAS NO IMPACT ON DEVICE PERFORMANCE. THE HYBRID FUNCTIONALITY WAS ACCEPTABLE. THE BATTERY VOLTAGE WAS 0.09 VOLTS. THE BATTERY WAS FOUND TO BE DEPLETED. NO ELECTRICAL ANOMALIES WITH THE HYBRID CIRCUIT OR BATTERY WERE FOUND, THEREFORE, NORMAL DEPLETION OF THE BATTERY IS ASSUMED. THERE WAS NO PARAMETER HISTORY AVAILABLE SO THE EXPECTED LIFE COULD NOT BE DETERMINED. THE #2 GROMMET WAS PARTIALLY LOOSE. THE SETSCREW(S) WERE BACKED OUT TOO FAR. THE TITANIUM CAN AND INSULATION COATING WERE SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED TELEMETRY WAS NOT POSSIBLE. INFO REC'D INDICATED A SUDDEN INTERRUPTION OF THE STIMULATION. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS REPLACED. THERE WAS NO INFO OR HISTORY ON USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC SWISS MANUFACTURING FACILITY 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention