BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2992462 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-12288
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. RESULTS: AS RECEIVED THE IPG WAS NON-RESPONSIVE. THE REPORTED COMPLAINT CANNOT BE ANALYZED AS THIS IS CONSIDERED TO BE A USER ERROR. ACCORDING TO THE EON MINI DFU REVIEW, THERE IS ADEQUATE INFORMATION 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." SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DID NOT CHARGE THE IPG FOR OVER 4 MONTHS DUE TO LOST CHARGER AND PROGRAMMER. THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE IPG WAS EXPLANTED AND REPLACED. FOLLOW-UP REVEALED THE PATIENT HAS EFFECTIVE STIMULATION COVERAGE. THE SJM REPRESENTATIVE ALSO EDUCATED THE PATIENT ON CHARGING GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91522 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2788115

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD: MODEL 3186 (3)| IMPLANT:| SCS EXTENSION: MODEL 3341| IMPLANT: