BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC IMPLANTABLE PULSE GENERATOR

    MDR report key: 1930205 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03579
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK OF DEVICE, THE IPG WAS TESTED BY THE PHYSICIAN'S OFFICE PERSONNEL ((B)(6)). SEVERAL ATTEMPTS WERE MADE TO ESTABLISH TELEMETRY WITH AND/OR ELICIT A RESPONSE FROM THE IPG; HOWEVER, NEITHER WAS POSSIBLE. THE IPG WAS RETURNED TO THE MFR FOR ANALYSIS. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3688 2864914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention