BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792035 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-02496
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. EVAL CODES: 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 RELATED TO THIS EVENT WERE FOUND. THE COMPLAINT THAT THE BATTERY WAS DEPLETED WAS CONFIRMED. AS RETURNED, THE IPG WOULD NOT COMMUNICATE DUE TO A DEPLETED BATTERY. THE BATTERY WAS RECOVERED AND THE IPG COMMUNICATED, CHARGED, AND WAS TESTED TO MFG SPECS USING THE AUTOTESTER. THE IPG PASSED ALL TESTS. PER THE EVENT DETAILS, THE PT STOPPED CHARGING THE IPG FOR OVER 30 DAYS. ACCORDING TO THE EON MINI DFU REVIEW, THERE IS ADEQUATE INFO FOR PRESERVING THE IPG WHEN NOT IN USE. THE DFU, PAGE 79, THE SHADED AREA ENTITLED "WARNING" STATES, "DO NOT LET AN IPG BATTERY REMAIN DEPLETED FOR AN EXTENDED PERIOD OF TIME. IF A DEPLETED BATTERY IS NOT RECHARGED WITHIN 30 TO 90 DAYS OF ITS FULL DISCHARGE, THE CHARGER MAY NOT BE ABLE TO RECHARGE IT; AND IT WILL HAVE TO BE SURGICALLY REPLACED TO RESUME THERAPY." 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 THE PT HAD NOT CHARGED HER IPG IN OVER 30 DAYS AND SHE CONSEQUENTLY LOST STIMULATION. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG. IT WAS REPORTED THE ISSUE WAS RESOLVED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3136615

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SCS LEAD: MODEL 3183| IMPLANT DATE: