BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 1924853 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03480
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE IPG FOUND BROKEN FEED THROUGH WIRES ON CHANNELS 15 AND 16 AND TEST DATA EXTRACTED FROM THE IPG INDICATED THAT THE PT HAD A STIM SET PROGRAM THAT UTILIZED THESE CHANNELS. 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

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008 CONSISTING OF AN IPG AND SURGICAL LEAD. IT WAS REPORTED ON (B)(6) 2010 THAT THE PT'S IPG WAS BEING REPLACED. THE DEVICE WAS ALLEGEDLY TURNING OFF WITHOUT PROMPTING. THE EXPLANT OCCURRED ON (B)(6) 2010. A DIAGNOSTIC TEST CONDUCTED BEFORE THE SURGICAL PROCEDURE REVEALED INVALID IMPEDANCE FOR ONE LEAD CONTACT. NO IMPEDANCE ISSUES WERE OBSERVED FOLLOWING THE PLACEMENT OF THE NEW IPG, SO THE SURGICAL LEAD REMAINS IMPLANTED. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR ANALYSIS. FOLLOW-UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 119609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention