BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON

    MDR report key: 3032377 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-06107
    Event Type
    Other
    Date Received
    March 29, 2013
    Date of Event
    March 5, 2012
    Report Date
    April 7, 2016
    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
    Health Professional
    N

    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. REF MFR REPORT: 1627487-2013-06108. IT WAS REPORTED THE PT HAS BEEN EXPERIENCING HEATING WHILE CHARGING. THE CHARGING SYSTEM HAS HEATED UP TO THE POINT THAT IT CAUSED A BLISTER. THE PT STATED HE HAS BEEN ATTEMPTING TO CONTACT SOMEONE ABOUT THE ISSUE FOR ABOUT A YR AND HAS MET WITH A SJM REP BUT CANNOT RECALL WHEN. A NEW LOW ENERGY CHARGER WAS SENT TO THE PT TO ADDRESS THE ISSUE. F/U INDICATES THE NEW CHARGER HAS RESOLVED THE HEATING ISSUE AND THE PT'S BLISTER IS HEALING WELL. ON (B)(4) 2012 ST JUDE MEDICAL, NEUROMODULATION DIV., 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 ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130371 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 171756

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| SCS LEAD: MODEL 3210| SCS LEAD: MODEL 3245| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3245| SCS LEAD: MODEL 3210