BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850268 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-06129
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 1, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    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 CORRECTION. 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

    DEVICE 1 OF 7. REFERENCE MFR REPORT: 1627487-2014-06130, 1627487-2014-06131, 1627487-2014-06132, 1627487-2014-006133, 1627487-2014-06134, 1627487-2014-06135. THE PATIENT IS IMPLANTED WITH TWO SEPARATE SCS SYSTEMS. THE PATIENT HAS TWO SCS EXTENSIONS (3383) WITH THE SAME LOT NUMBER OF 97326. THE PATIENT ALSO HAS TWO SCS EXTENSIONS (3383) WITH THE SAME LOT NUMBER OF R171487. IT WAS REPORTED THE PATIENT'S FIRST SCS SYSTEM BEGAN TO SHOCK HIM SOON AFTER IMPLANT AND HE EXPERIENCED EXCESSIVE HEAT WHEN RECHARGING. THE PATIENT'S SECOND SCS SYSTEM GAVE HIM RED RASHES AT THE IMPLANT SITE WHEN RECHARGING AND SHOCKED HIM AS WELL. THE PATIENT REPORTS BOTH OF HIS SCS SYSTEMS ARE NO LONGER FUNCTIONING AND HE IS REQUESTING TO HAVE BOTH SCS SYSTEMS REMOVED. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291639 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 96423

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other