BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYS

    MDR report key: 3950170 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-00396
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL IS ASSOCIATED WITH A FIELD CORRECTION. DEVICE EVALUATED BY MFR: CORRECTIVE AND PREVENTATIVE 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 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 2 OF 2. REFERENCE MFR REPORT #: 1627487-2014-00395.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376674 CHARGING SYS SCS CHARGING SYS GZB ST. JUDE MEDICAL - NEUROMODULATION 3711 4220815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other