BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3201568 · Received June 28, 2013

    Report

    Report Number
    1627487-2013-05937
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 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

    RESULTS: THE RETURNED IPG SUCCESSFULLY COMMUNICATED WITH A TEST STANDARD PROGRAMMER AND DISPLAYED A LOW BATTERY WARNING MESSAGE. AN ESTIMATE OF LONGEVITY WAS MADE USING THE CALCULATOR FROM DOCUMENT (B)(4) AND THE PATIENT PROGRAM PARAMETERS RETRIEVED FROM THE WDL REGISTER DOWNLOAD. IT WAS DETERMINED THAT THE IPG SHOULD LAST FOR APPROXIMATELY 32.6 MONTHS AT PERCEPTION SETTINGS AND APPROXIMATELY 7.1 MONTHS AT COMFORT LEVEL. THE IPG WAS IMPLANTED FOR APPROXIMATELY 32.5 MONTHS. THIS IS CONSIDERED TO BE NORMAL BATTERY DEPLETION. 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'S IPG WAS EXPLANTED AND REPLACED (WITH A DIFFERENT MODEL PER THE MANUFACTURER'S DEVICE RECORD DATABASE) DUE TO THE IPG ALLEGEDLY REACHING END-OF-LIFE. THE REPLACEMENT IPG ADDRESSED THE PATIENT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296859 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3143565

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other IMPLANT:| IMPLANT:| SCS ANCHORS, MODEL: 1192 (X2)| SCS LEADS, MODEL: 3186 (X2)