BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 2170196 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-01719
    Event Type
    Other
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: INITIAL COMMUNICATION WITH THE RETURNED IPG USING THE LAB PT PROGRAMMER DISPLAYED THE "IPG BATTERY LOW" WARNING MESSAGE. THE LOW BATTERY FLAG WAS CLEARED FOLLOWED BY PERFORMING A PULSE LOAD TEST TO CLEAR PASSIVATION. POST PULSE LOAD TEST, THE LOW BATTERY FLAG DID NOT RETURN, INDICATING THE LOW BATTERY WARNING WAS DUE TO PASSIVATION. THE IPG PASSED ALL FUNCTIONAL TESTS ON THE AUTO-TESTER. 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 (B)(6) RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, IN (B)(6) 2009. IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED EARLY BATTERY DEPLETION. THE PT ALLEGEDLY HAD NOT LOST STIMULATION. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2011. NO FURTHER PT ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3608 2812935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention