BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2971072 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-04198
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 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 CODES: RESULTS: POCKET HEATING WAS CONFIRMED. THE INVESTIGATION FOR (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: 1627487-2013-04197. IT WAS REPORTED THE PATIENT HAD DIFFICULTY CHARGING, AND WAS EXPERIENCING HEATING WHILE CHARGING THE IPG. THE PATIENT ALSO REPORTED THE AC ADAPTER WOULD GET HOT. THE SJM REPRESENTATIVE MET WITH THE PATIENT, AND WAS ABLE TO ESTABLISH COMMUNICATION WITHOUT INCIDENT. DURING THE CHARGING SESSION, THE PATIENT STATED SHE COULD NOT DISTINGUISH IF THERE WAS HEATING. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT. FOLLOW UP IDENTIFIED THE ISSUE HAD RESOLVED. IT WAS REPORTED THE HEATING ISSUE WAS ONLY PRESENT IF THE PATIENT WAS MOVING AROUND WHILE CHARGING. THE PATIENT WAS ADVISED TO CHARGE MORE FREQUENTLY FOR LESS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69638 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3711 3779187

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3166| SCS LEAD: MODEL 3163| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT:| SCS EXTENSION: MODEL 3341 (2)| IMPLANT: