BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1895449 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03175
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. ONE UNIT OUT OF THE LOT OF 30 WAS FOUND TO HAVE A DAMAGED LID. THE AFFECTED UNIT WAS REMOVED FROM THIS PRODUCTION LOT NUMBER AND THE REMAINING BALANCE WAS APPROVED FOR USE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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

    ON (B)(6) 2010, THE PT ((B)(6)) WAS IMPLANTED WITH AN IPG, PERCUTANEOUS LEAD AND TWO EXTENSIONS. FOLLOWING THE PROCEDURE, FIVE OF THE LEAD CONTACTS YIELDED HIGH IMPEDANCE READINGS. THE PT UNDERWENT AN ADD'L SURGICAL PROCEDURE AT WHICH TIME THE PHYSICIAN REINSERTED THE EXTENSION INTO THE IPG HEADER. A SUBSEQUENT IMPEDANCE TEST WAS PERFORMED, AND ALL CONTACTS WERE IN THE NORMAL RANGE. NO DEVICES WERE EXPLANTED AND NONE WILL BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3161516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention