BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112913 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-24198
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    July 11, 2014
    Report Date
    April 28, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT 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 MANUFACTURING SPECIFICATIONS USING THE AUTO-TESTER. THE IPG PASSED ALL TESTS. 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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-24197. IT WAS REPORTED THE PT IS WITHOUT STIMULATION AND COMMUNICATION COULD NOT BE ESTABLISHED BETWEEN THE PT'S 2 IPG'S AND CHARGING SYSTEM. TROUBLESHOOTING AND A REPLACEMENT CHARGING SYSTEM DID NOT RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY TAKEN PLACE AT A LATER DATE.

    Description of Event or Problem · 1

    DEVICE 2 OF 2.REFERENCE MFR REPORT#1627487-2014-24197.FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING THE PATIENT'S TWO IPGS.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT#1627487-2015-24197.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577224 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3845086

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SCS LEAD: MODEL 3189| IMPLANTED:| SCS LEAD: MODEL 3186 (2)| IMPLANTED: