BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 5150266 · Received October 14, 2015

    Report

    Report Number
    1627487-2015-10281
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 18, 2015
    Report Date
    December 3, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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.(B)(4)

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE HER IPG WAS REPLACED WITH A NEW ONE, WHICH RESOLVED THE ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STARTED EXPERIENCING PAIN AND WARMING AT THE IPG SITE WHILE CHARGING AFTER SHE FELL OFF A LADDER AND LANDED DIRECTLY ON HER IPG. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678919 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3612449

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other