BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3221777 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-06575
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 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. EVAL RESULTS : POCKET HEATING WAS CONFIRMED. THE INVESTIGATION FOR CAPA (B)(4) ASSOCIATED WITH HEATING WHILE 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: 1627487-2013-06574. IT WAS REPORTED THE PT EXPERIENCED HEATING WHILE CHARGING HER IPG. AN SJM REP CONTACTED THE PT AND SHE STATED THAT SHE HAD NOT FOLLOWED HER NORMAL CHARGING SCHEDULE AND HAD TO CHARGE FOR A LONGER PERIOD OF TIME WHEN SHE EXPERIENCED THE HEATING. THE PT WILL TRY CHARGING HER IPG FOR SHORTER INTERVALS. THE REP ADVISED THE PT TO CALL SJM IF THE HEATING PERSISTS. ON 08/01/2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PT RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEARING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312947 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3711 3586780

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1194| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE: