BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4803300 · Received May 28, 2015

    Report

    Report Number
    1627487-2015-06234
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    November 23, 2014
    Report Date
    June 3, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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.

    Description of Event or Problem · 1

    DEVICE 1 OF 2 REFERENCE MFR. REPORT #1627487-2015-06235 ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE REPLACEMENT CHARGING SYSTEM REPORTEDLY RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT #1627487-2015-06235. THE PATIENT REPORTED SHE EXPERIENCED SCS IPG POCKET HEATING WHILE CHARGING. A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PATIENT AS THE NEXT COURSE OF ACTION 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
    344913 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3636226

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other MODEL 3286, SCS LEAD| MODEL 1192 (X2), SCS ANCHOR