BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3012141 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-06055
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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. MFR'S EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. 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 E 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 4 OF 4. REFERENCE MFR REPORT: 1627487-2013-06052, 06053, 06054. IT WAS REPORTED THE PT EXPERIENCES HEATING WHILE RECHARGING. THE PT HAS TWO SYSTEMS, BUT HE STATED HE ONLY USES ONE CHARGER TO CHARGE BOTH IPGS AND HE EXPERIENCES HEATING WHEN CHARGING BOTH IPGS. ALSO, THE PT REQUESTED ONLY ONE REPLACEMENT CHARGER BE SENT AS HE DOES NOT WANT TO HAVE TWO CHARGERS. A LOW ENERGY CHARGER WAS SENT TO ADDRESS THIS ISSUE. F/U INDICATES THE NEW CHARGER IS WORKING FINE AND THE PT IS NO LONGER EXPERIENCING ANY HEATING WHILE CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106491 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3449505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS LEAD: MODEL 3286| IMPLANT DATE:| SCS LEAD: MODEL 3228| IMPLANT DATE: