BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 5238982 · Received November 20, 2015

    Report

    Report Number
    1627487-2015-09018
    Event Type
    Injury
    Date Received
    November 20, 2015
    Report Date
    December 21, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONTACT INFO INADVERTENTLY ENTERED INCORRECTLY FROM PREVIOUS SUPPLEMENTS. 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

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2015 DURING WHICH TIME THE PHYSICIAN EXPLANTED AND REPLACED THE IPG WITH AN UPDATED MODEL.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED THE ISSUE IS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT INADVERTENTLY HIT THE IPG SITE. SINCE THAT TIME, SHE'S EXPERIENCED BURNING AND STINGING SENSATIONS AT THE IPG SITE REGARDLESS OF STIMULATION BEING ON OR OFF. REPORTEDLY, X-RAYS WERE ORDERED AND RESULTS WERE NORMAL. SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769881 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3788 4595092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other