BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3823392 · Received March 26, 2014

    Report

    Report Number
    1627487-2014-21185
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 5, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 EXPERIENCED INTERRUPTED COMMUNICATION WITH HER CHARGING SYSTEM. AS A RESULT, A REPLACEMENT CHARGER WAS SENT TO THE PATIENT. FOLLOW-UP IDENTIFIED THE PATIENT WAS UNABLE TO LOCATE THE IPG WITH BOTH CHARGING SYSTEMS. THE SJM REPRESENTATIVE CONFIRMED THE LOSS OF COMMUNICATION WITH MULTIPLE EXTERNAL DEVICES. THE PATIENT HAD LAST SUCCESSFULLY CHARGED THE IPG IN JANUARY AND SHE CURRENTLY DOES NOT HAVE STIMULATION. THE PATIENT WILL UNDERGO A MYELOGRAM, AFTER WHICH IPG REPLACEMENT WILL BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176286 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2837494

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANTED:| SCS LEAD, MODEL 3219