BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3862821 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-01331
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 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. MANUFACTURER'S EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVAL RESULTS: POCKET HEATING WAS CONFIRMED. THE INVESTIGATION 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 IPG'S 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 #1627487-2014-01330. IT WAS REPORTED THE PT EXPERIENCED POCKET HEATING WHILE RECHARGING. THE PT HAS NOT CHARGED THE IPG IN SEVERAL MONTHS DUE TO THE HEATING ISSUE AND A PREVIOUS SPINAL FUSION PROCEDURE. FOLLOW UP ON THIS MATTER FOUND THE PT IS CURRENTLY WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH HIS IPG USING EITHER THE CHARGING SYSTEM OR PROGRAMMER. AN SJM REP HAS BEEN CONTACTED TO FURTHER INTERROGATE THE PT'S IPG. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTTS 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 WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309065 CHARGING SYSTEM SCS CHARGING SYSTEM GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3721 3178883

    Patients

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