BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 4399449 · Received January 8, 2015

    Report

    Report Number
    1627487-2015-06019
    Event Type
    Injury
    Date Received
    January 8, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    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

    IT WAS REPORTED, THE PATIENT IS EXPERIENCING THE "IPG HEATING UP" AND AS A RESULT, PLANS TO PURSUE SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT STATED TO HAVE TURNED HER SCS SYSTEM OFF APPROXIMATELY TWO YEARS AGO. SURGICAL INTERVENTION REMAINS PENDING AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2015 AT WHICH TIME THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS REPORTEDLY RESTORED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15644 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 174191

    Patients

    Seq Age Sex Outcome Treatment
    1