BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2921686 · Received January 15, 2013

    Report

    Report Number
    1627487-2013-05086
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    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 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 RECEIVED A LOW BATTERY WARNING AND HAD LOST STIMULATION. LONGEVITY CALCULATIONS WERE PERFORMED AND REVEALED THE IPG HAD REACHED END-OF-LIFE PREMATURELY. AN SCS REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE IPG WAS NON-FUNCTIONAL. AS A RESULT, THE PATIENT'S IPG WAS EXPLANTED AND REPLACED (WITH A DIFFERENT MODEL). STIMULATION WAS REGAINED POST-OP. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22095 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3722559

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCS LEAD, MODEL: 3219| IMPLANT: