BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2792003 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-12266
    Event Type
    Injury
    Date Received
    October 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CHARGER MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. MFR'S EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA). EVAL: RESULT: POCKET HEATING 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 TEMP 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 # 1627487-2012-12265. IT WAS REPORTED THE PT FELT HEATING AT THE IPG POCKET SITE WHILE CHARGING. REPORTEDLY THE PT NOTICED A PINK AREA ON THE SKIN AT THE IPG SITE. IT WAS ALSO REPORTED THE SJM REP INTERROGATED THE SYSTEM AND FOUND THE CHARGER WOULD NOT TURN ON, A REPLACEMENT WAS SENT. THE NEXT COURSE OF ACTION WAS UNDETERMINED. ON (B)(6) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIV., 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 WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS IPG CHARGER LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3576141

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3245| SCS EXT: MODEL 3386