BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2992476 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-04266
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    December 4, 2012
    Report Date
    February 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT HAD NOT RECHARGED THE IPG FOR SIX MONTHS, AND THE CHARGING SYSTEM WOULD NOT COMMUNICATE WITH THE IPG. THE PT REPORTED HE HAD ISSUES WITH THE CHARGING SYSTEM LOCATING THE IPG PREVIOUSLY REPORTED TO SJM. THERE WAS NO PREVIOUS ISSUE IN THE DEVICE MANUFACTURER'S SYSTEM. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. FOLLOW UP IDENTIFIED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91611 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 46407A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3146 (2)| SCS LEAD: MODEL 3186