BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 4112675 · Received September 10, 2014

    Report

    Report Number
    1627487-2014-12593
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    August 15, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CHARGER MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. MANUFACTURER'S EVALUATION: CORRECTIVE AND PREVENTATIVE ACTION (CAPA). EVALUATION CODES: 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 HEAT. 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 #: 1627487-2014-12592. IT WAS REPORTED THE PATIENT STARTED EXPERIENCING UNCOMFORTABLE HEAT WHEN CHARGING ABOUT THREE MONTHS AGO. THE PATIENT STOPPED USING AND CHARGING THE SCS SYSTEM. A REPLACEMENT CHARGER WAS SENT TO THE PATIENT. 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 WERE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559691 CHARGING SYSTEM SCS CHARGER GZB ST. JUDE MEDICAL - NEUROMODULATION 3701 46160

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other IMPLANT DATE:| SCS LEAD :MODEL 3214