BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2844433 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-02682
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02683. IT WAS REPORTED, THE PT COMPLAINED OF PAIN AT HIS IPG SITE WHILE SITTING FOR LONG PERIODS OF TIME. HE STATED, HE DID NOT EXPERIENCE THE PAIN WHILE WALKING OR LAYING DOWN. IT WAS REPORTED, THE PHYSICIAN SUSPECTS THE PAIN IS RELATED TO THE IPG PRESSING ON A NERVE. THE PT ALSO STATED, HE CHARGES HIS IPG ON A MONTHLY BASIS AND EXPERIENCES POCKET HEATING WHILE CHARGING. THE SJM REPRESENTATIVE ADVISED THE PT OF CHARGING PRECAUTIONS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. ON 08/01/2012, 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 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3145885

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3228