BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2003759 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01178
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    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: 1627487-2011-01179. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2008. IT WAS REPORTED THAT THE PT COMPLAINED OF BULKINESS AND IRRITATION FROM THE IPG. THE PT REPORTED THAT HE FELT PAINFUL STIMULATION IN THE RIGHT RIBS AND ABDOMEN; HE REPORTED NO FALLS OR HEAVY LIFTING. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. X-RAYS SHOWED THAT THE LEAD HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG AND LEAD ON (B)(6) 2011. THE IPG WAS REPLACED WITH A SMALL MODEL, AND THE LEAD WAS REPLACED WITH A DIFFERENT MODEL SURGICAL LEAD. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL -NEUROMODULATION DIV. 3716 119940

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention