BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2000843 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-00221
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    March 19, 2010
    Report Date
    January 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00222. THE PT RECEIVE HER SCS SYSTEM ON (B)(6) 2008, CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS. IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED ON (B)(6) 2010 DUE TO INEFFECTIVE STIMULATION AND THE PT'S NEED FOR AN MRI. THE PT REPORTEDLY UNDERWENT BACK SURGERY TO ALLEVIATE THE PAIN PATTERN THAT HER SCS SYSTEM WAS INTENDED TO COVER. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 84108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention