BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3134041 · Received May 23, 2013

    Report

    Report Number
    1627487-2013-08136
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    October 14, 2010
    Report Date
    April 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: NEW PROCESS MONITORING EQUIPMENT NO RECORDING DATA ACCURATELY, STERILE LOT 080915. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-08137. IT WAS REPORTED THE PT HAD THE SYSTEM EXPLANTED DUE TO A (B)(6) INFECTION AND WAS REFERRED TO A PHYSICIAN. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229170 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2843104

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention