BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3110869 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-04574
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    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. 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 CHARGES WERE CAPABLE OF ELEVATED HEATING. SJM HAS LIMITED INFO 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. REF MFR REPORTS: 1627487-2013-04572, 1627487-2013-04573. IT WAS REPORTED THE PT WAS EXPERIENCING HEATING WHILE RECHARGING THE IPG WITH THE CHARGING SYSTEM. IN ADDITION, THE PT REPORTED THE IPG WAS SUPERFICIAL, AND WAS CAUSING THE AREA AROUND THE IPG TO BE UNCOMFORTABLE. THE PT REPORTED WHEN HE WEARS JEANS, THEY RUB ON THE IPG SITE. IT WAS ALSO REPORTED THE PT HAD NOT RECEIVED EFFECTIVE STIMULATION RELIEF, AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT HAD REQUESTED FOR THE SCS SYSTEM TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202556 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST JUDE MEDICAL - NEUROMODULATION 3721 3503164

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention