BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2722560 · Received August 29, 2012

    Report

    Report Number
    1627487-2012-12019
    Event Type
    Injury
    Date Received
    August 29, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2012-12018. IT WAS REPORTED, THE PT HAS NOT USED THE SYSTEM SINCE (B)(6) 2012. THE IPG TURNED OFF BY ITSELF. HE HAS BEEN UNABLE TO ESTABLISH COMMUNICATION BETWEEN THE PROGRAMMER AND THE IPG. ATTEMPTS TO ESTABLISH COMMUNICATION WITH OTHER EXTERNAL DEVICES WAS NOT SUCCESSFUL. IT WAS ALSO REPORTED THE CHARGER HEATS UP WITHIN THE FIRST 10-15 MINUTES OF CHARGING. IT WAS REPORTED, THE DOCTOR IS GONG TO REPLACED THE IPG. ON 08/01/20012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS IPG CHARGER LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3370705

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANTED: