BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1930114 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03599
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE IPG WAS RECEIVED WITH ONE PORT-PLUG INSERTED INTO THE TOP OF THE HEADER AND THE BOTTOM SETSCREW WAS UPSIDE DOWN IN THE CONNECTOR BLOCK. NO VISUAL ANOMALIES WERE NOTED. ONCE THE BOTTOM SEPTUM WAS REMOVED AND THE SETSCREW WAS RESEATED, THE SETSCREW FUNCTIONS NORMALLY. THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. 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

    THE IPG WAS RETURNED TO THE MANUFACTURER AFTER THE PHYSICIAN COULD NOT SEAT THE SETSCREW DURING AN IMPLANT ATTEMPT. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3101643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention