BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3022430 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-15399
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 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 NUMBER WAS ASSOCIATED WITH A FIELD CORRECTION. MFRS EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA). EVAL CODES RESULTS CODE: 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 INFO 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: 1627487-2013-15398. IT WAS REPORTED THE PATIENT IS EXPERIENCING AN EXTREMELY UNCOMFORTABLE HEATING SENSATION WHILE CHARGING HER IPG. THE PATIENT STATED THE SENSATION CONTINUES FOR A FEW MINUTES AFTER SHE STOPPED CHARGING. THE PATIENT WAS SENT A REPLACEMENT CHARGING SYSTEM. FOLLOW-UP INDICATED THE PATIENT STATED SHE WAS CHARGING BY PLACING THE CHARGER WAND DIRECTLY OVER HER SKIN. THE PATIENT WAS ADVISED TO USE THE CHARGING BELT OR PLACE THE WAND OVER HER CLOTHES. ADD¿L FOLLOW-UP INDICATED THE PATIENT¿S REPLACEMENT CHARGING SYSTEM IS FUNCTIONING PROPERLY. HOWEVER, THE PATIENT IS UNSURE IF HER POCKET SITE IS STILL BURNING BECAUSE SHE FEELS LIKE SHE HAS A SUNBURN UNDER HER SKIN AND THE IPG SITE IS SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119855 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL NEUROMODULATION 3721 3741920

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR SCS LEAD: MODEL 3219| IMPLANT DATE: