BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 6062153 · Received October 27, 2016

    Report

    Report Number
    1627487-2016-05604
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 4, 2016
    Report Date
    January 10, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 162487-07262012-002-R, 162487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN MULTIPLE FIELD ADVISORIES. 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.

    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: 1627487-2016-05605. IT WAS REPORTED THE PATIENT IS EXPERIENCING WARMTH AT THE IPG SITE AFTER CHARGING. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE. ON (B)(6) 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.

    Description of Event or Problem · 1

    DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2016-05605.

    Description of Event or Problem · 1

    DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2016-05605. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2016 WHERE THE IPG WAS REMOVED AND REPLACED. ISSUE HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713619 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2878010

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MODEL 3219, SCS LEAD