BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 4879499 · Received June 30, 2015

    Report

    Report Number
    1627487-2015-08382
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    May 23, 2015
    Report Date
    September 28, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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

    THE REPORT NUMBER WAS INADVERTENTLY ENTERED INCORRECTLY. 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

    IT WAS REPORTED THE PATIENT RECEIVED A LOW BATTERY WARNING ON THE PATIENT PROGRAMMER. DIAGNOSTIC TESTING REVEALED LOW IMPEDANCE VALUES. NO FURTHER INFORMATION IS AVAILABLE ON THE NEXT COURSE OF ACTION AT THIS TIME.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2015 DURING WHICH TIME THE IPG WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. EFFECTIVE THERAPY WAS RESTORED POSTOPERATIVELY. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423733 EON C 16-CHANNEL IPG SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 4073491

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR