BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2892893 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-02925
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODUALTION
    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 ASSOCIATED WITH A FIELD CORRECTION. MANUFACTURER'S EVALUATION: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVALUATION: 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: 1627487-2012-02924. IT WAS REPORTED, THE PT EXPERIENCED AN EXTREME HEATING SENSATION AFTER 3-5 MINUTES OF CHARGING HIS IPG. THE PT STATED IT FELT LIKE THE HEAT WAS COMING FROM THE CHARGER ANTENNA AND NOT THE IPG SITE. HE ALSO REPORTED, HE EXPERIENCED INTERMITTENT CHARGING AS HIS CHARGER FREQUENTLY LOSES COMMUNICATION WITH HIS IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS 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 AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODUALTION 3721 3865798

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)