BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 1924515 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03456
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 3. REFERENCE MFR. REPORT # 1627487-2010-03457 AND 1627487-2010-03458. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008 CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS. THE LEADS WERE IMPLANTED IN THE OCCIPITAL AREA (OFF-LABEL INDICATION). IT WAS REPORTED THAT THE PT'S IPG AND LEADS WERE REPLACED ON (B)(6) 2010 DUE TO LEAD FRACTURE. THE PT REPORTEDLY EXPERIENCED A GRADUAL LOSS OF STIMULATION. PREVIOUS DIAGNOSTIC TESTS ON THE LEAD(S) REVEALED INVALID IMPEDANCE READINGS. F/U ON THE PT FOUND NOT FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL -NEUROMODULATION DIVISION 3716 97741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention