BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2251210 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-04193
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN (B)(4). SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THE PT NO LONGER HAD STIMULATION. THE SJM REPRESENTATIVE ATTEMPTED TO REPROGRAM THE PT, BUT THE ISSUE WAS NOT RESOLVED. AN X-RAY WAS PERFORMED, AND IT WAS REPORTED THE SYSTEM LOOKED TO BE CORRECTLY PLACED. THE PT'S PHYSICIAN WAS TO BE CONSULTED ABOUT A POSSIBLE REPLACEMENT. IT WAS REPORTED THE PT DID NOT WANT A PROCEDURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 175824

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3189