BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 5823678 · Received July 26, 2016

    Report

    Report Number
    1627487-2016-03819
    Event Type
    Injury
    Date Received
    July 26, 2016
    Report Date
    September 16, 2016
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    PP010032
    Adverse Event
    Yes
    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

    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 SUFFERED A RECENT FALL WITH IMPACT TO THE IPG. SOON AFTER THE INCIDENT, STIMULATION WOULD POWER ON AND OFF WITHOUT PROMPTING. REPORTEDLY, THE PATIENT IS ELECTING A NON-RECHARGEABLE DEVICE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION. CONCOMITANT MEDICAL DEVICES AND THERAPY DATES: UNKNOWN AT THIS TIME. DATE OF BIRTH: UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2016 DURING WHICH TIME THE ENTIRE SCS SYSTEM WAS EXPLANTED AND REPLACED WITH 2 DRG LEADS FOR BILATERAL FOOT COVERAGE. POSTOPERATIVELY, STIMULATION WAS SUCCESSFULLY RESTORED AND COVERAGE TO THE PATIENT'S SATISFACTION. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475292 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3716 113540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other