BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2820133 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02602
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMDULATION
    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: 1627487-2012-02601. IT WAS REPORTED THE PT FELT UNCOMFORTABLE HEATING AT HIS IPG POCKET SITE WHILE CHARGING. THE PT STARTED HE HAS LOST ABOUT 30 POUNDS AND HIS IPG IS MORE SUPERFICIAL. IT WAS REPORTED THE PT HAS A FREQUENT RECHARGE BURDEN DUE TO HIS SYSTEM'S HIGH POWER REQUIREMENTS AND HE TYPICALLY CHARGES FOR 3-4 HOURS PER DAY. FOLLOW-UP IDENTIFIED THE PT'S STIMULATION TURNED OFF ON ITS OWN. THE PT REPORTED THIS ISSUE OCCURS ABOUT ONE WEEK PER MONTH. THE PT ALLEGEDLY WAS ABLE TO TURN THE STIMULATION BACK ON USING HIS PROGRAMMER. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMDULATION 3721 3223540

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)