BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2993957 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10068
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 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
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CHARGER MODEL NUMBER WAS ASSOCIATED IN A FIELD CORRECTION. MFR'S EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA). 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 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: 1627487-2013-10067. IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCES HEATING WHILE CHARGING HIS IPG STATING THAT THE SKIN AROUND THE IPG SITE GETS VERY HOT. IT WAS ALSO REPORTED THE PATIENT¿S RECHARGE BURDEN HAS INCREASED. A REPLACEMENT CHARGING SYSTEM WAS ISSUED TO THE PATIENT. IN ADDITION, THE PATIENT WAS PROVIDED WITH THE MFR SUGGESTIONS TO AVOID HEAT WHILE CHARGING THE IPG. FOLLOW UP INFO REVEALED THE REPLACEMENT CHARGING SYSTEM HAS IMPROVED THE PATIENT¿S RECHARGE BURDEN; HOWEVER, HE IS STILL EXPERIENCING THE HEATING SENSATION WHEN CHARGING HIS IPG. IT WAS REPORTED THE NEXT PLANNED COURSE OF ACTION WILL BE TO REPROGRAM THE IPG. PLEASE NOTE: THE IPG WAS IMPLANTED IN 2009 (EXACT DATE UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89256 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3711 3825913

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention