BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC CONVENTIONAL IPG

    MDR report key: 1990671 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01114
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    THE PT ((B)(6)) REC'D HER SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT AFTER THE IPG WAS IMPLANTED, THE PT PROGRAMMER REVEALED AN IPG BATTERY LOW MESSAGE. IT WAS REPORTED THAT THE LOW BATTERY MESSAGE WAS MOST LIKELY RELATED TO BATTERY PASSIVATION. THE PHYSICIAN DECIDED TO OPEN THE IPG POCKET IN ORDER TO EXPLANT AND REPLACE THE IPG DURING THE PROCEDURE. THE LOW BATTERY MESSAGE WAS SUCCESSFULLY CLEARED THE NEXT DAY FOLLOWING THE EXPLANT PROCEDURE. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3688 3136267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention