BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 6143153 · Received December 2, 2016

    Report

    Report Number
    1627487-2016-06228
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 16, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    (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).

    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'S IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HIS IPG AND EXTERNAL DEVICES. THE IPG IS INOPERABLE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION AT WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS RESTORED POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793560 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3996007

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other MODEL 3183, SCS LEAD| MODEL 3245, SCS LEAD