BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3161458 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02783
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 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
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST STIMULATION. HE REPORTED HIS PROGRAMMER DISPLAYED A MESSAGE REGARDING HIS IPG BATTERY THAT APPEARED TO BE A LOW BATTERY MESSAGE. FOLLOW-UP INDICATED THE PHYSICIAN PLANS TO REPLACE THE PATIENT'S IPG WITH A RECHARGEABLE MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249215 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3166066

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS EXTENSION: MODEL 3383 (2)| SCS LEAD: MODEL 3219| IMPLANT DATE:| IMPLANT DATE: