BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC CONVENTIONAL IPG

    MDR report key: 1960449 · Received December 16, 2010

    Report

    Report Number
    1627487-2010-03443
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 RECEIVED HIS SCS SYS ON (B)(6) 2010. IT WAS REPORTED THAT THE PT RECEIVED AN "IPG BATTERY LOW" MESSAGE. A REP OF SJM MET WITH THE PT AND PERFORMED A LONGEVITY CALCULATION. IT WAS REPORTED THAT THE IPG SHOULD LAST BETWEEN 9-10 YEARS BASED ON THE PROGRAMMED SETTINGS, AND THE MESSAGE WAS MOST LIKELY RELATED TO BATTERY PASSIVATION. F/U ON THE PT FOUND THAT THE PASSIVATION MESSAGE WAS CLEARED. THE PT WAS REPROGRAMMED WITH HIGHER PARAMETERS AND THE ISSUE WAS CORRECTED.

    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 3112878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention