BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYS

    MDR report key: 3231585 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-03977
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    December 13, 2012
    Report Date
    June 19, 2013
    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 CHARGER MODEL WAS INCLUDED IN A FIELD CORRECTION. MANUFACTURER'S EVALUATION: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVALUATION: RESULT: POCKET HEATING WAS CONFIRMED. THE INVESTIGATION FOR CAPA (B)(4) ASSOCIATED WITH HEATING WHILE CHARGING (POCKET HEATING) CONCLUDED THAT THE CHARGER WAS CAPABLE OF TRANSFERRING ENERGY TO THE IPG AT A RATE THAT WOULD CAUSE HEATING OF THE IPG AND/OR CHARGING WAND OF SUFFICIENT ELEVATED TEMPERATURE TO CAUSE PAIN AND BURNS. THE HEATING WHILE CHARGING WAS DETERMINED TO BE EXACERBATED BY OFF-AXIS CHARGING OF SHALLOW IMPLANTED IPGS AND THAT ALL CHARGERS WERE CAPABLE OF ELEVATED HEATING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-03976. IT WAS REPORTED THE PT EXPERIENCED A BURNING SENSATION AT HER SCS IPG POCKET SITE AS WELL AS HER SCS IPG OVERHEATING. THE PT'S SCS IPG WAS ELECTIVELY REPLACED DURING A PREVIOUS LEAD REPLACEMENT PROCEDURE. ADDITIONALLY, AT THIS TIME, IT IS UNK WHETHER OR NOT THE PT'S CHARGING SYS IS RELATED TO THE OVERHEATING ISSUE; THEREFORE, THE CHARGING SYS IS BEING REPORTED AS DEVICE 2. ON (B)(6) 2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. 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
    323798 CHARGING SYS SCS CHARGING SYS LGW ST JUDE MEDICAL - NEUROMODULATION 3711 2773420

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)