BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 4091882 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-02593
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 ASSOCIATED WITH A FIELD CORRECTION. CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. RESULTS: 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2014-02591, 16267487-2014-02592. THE MANUFACTURER'S PATIENT DATABASE INDICATES THE PATIENT HAS TWO 3701 MODEL CHARGERS. IT IS UNDETERMINED WHICH CHARGER CAUSED THE HEATING ISSUE. THEREFORE, ALL POSSIBLE DEVICES ARE BEING REPORTED. IT WAS REPORTED THE PATIENT IS EXPERIENCING DIFFICULTY COMMUNICATING WITH HIS SCS IPG AND THE CHARGER. ALSO, THE PATIENT STATED HE EXPERIENCED POCKET HEATING WHEN CHARGING HIS IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT TO ADDRESS THE ISSUE. ST. JUDE MEDICAL, NEUROMODULATION DIVISION, HAS 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
    526437 CHARGING SYSTEM SCS CHARGING SYSTEM GZB ST. JUDE MEDICAL - NEUROMODULATION 3701 4275829

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other