BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2030881 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-00375
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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

    THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT SHE WAS UNABLE TO COMMUNICATE WITH THE DEVICE USING TWO CHARGING SYSTEMS. DIAGNOSTIC TESTS WERE PERFORMED; HOWEVER, NO IMPEDANCE ISSUES WERE OBSERVED. THE ALLEGED CHARGING ISSUE WAS BELIEVED TO THE RESULT OF BOTH THE LOCATION AND THE IMPLANT DEPTH OF THE IPG. SURGICAL INTERVENTION WAS UNDERTAKEN TO RESOLVE THIS MATTER; AT WHICH TIME, THE PHYSICIAN ELECTED TO REPLACE THE PT'S IPG. THE PT IS REPORTEDLY RECEIVING EFFECTIVE STIMULATION COVERAGE SINCE THE PROCEDURE.

    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 DIVISION 3788 2802316

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219