BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2820157 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02600
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    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. 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: 1627487-2012-02599. IT WAS REPORTED THE PT EXPERIENCED A SHOCKING SENSATION, PAIN AND REDNESS AT THE IPG SITE WHILE CHARGING HER IPG. THE PT REPORTED SHE WENT TO THE EMERGENCY ROOM DUE TO THE DISCOMFORT AND WAS DIAGNOSED WITH A FIRST DEGREE BURN OVER THE IPG SITE. SHE TREATED THE BURN WITH SILVADENE CREAM AND REGULAR DRESSING CHANGES. SHE STATED BLISTERS DEVELOPED OVER THE AREA AND SHE WAS AFRAID TO RECHARGE HER IPG DUE TO THE ISSUE. SHE ALSO REPORTED HER STIMULATION WAS SIGNIFICANTLY LESS EFFECTIVE SINCE THE INCIDENT. THE PT'S IPG WAS EXPLANTED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ON (B)(6) 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 WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3599584

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD: MODEL 3288| IMPLANT DATE: