BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3010547 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01278
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    November 8, 2012
    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. MANUFACTURER'S EVALUATION: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVALUATION: RESULT: 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-1277. IT WAS REPORTED THE PT HAS EXPERIENCED INTENSE HEAT AT HER IPG SITE DURING CHARGING SINCE HER SCS SYSTEM IMPLANT. A NEW LE CHARGER WAS SENT TO THE PT TO ADDRESS THE ISSUE. IT WAS ALSO REPORTED THE PT IS EXPERIENCING DISCOMFORT AT HER IPG SITE. THE PT'S IPG IS SUPERFICIAL DUE TO WEIGHT LOSS. THE PT WAS ADVISED TO CONSULT HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108281 CHARGING SYSTEM SCS CHARGER LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3828703

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3219| IMPLANT DATE:| IMPLANT DATE: