BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2792243 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-11468
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    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
    IN, 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: 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 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 3. REFERENCE MFR REPORT: 1627487-2012-11467, 1627487-2012-11469. THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT HAD RECEIVED THE CHARGING NOTIFICATION LETTER, AND HER HUSBAND CALLED TO REPORT THE SCS WAS EXPLANTED SOMETIME AFTER IMPLANT. IT WAS REPORTED, THE PATIENT DID NOT LIKE THE STIMULATION PATTERN SHE RECEIVED. IN ADDITION, IT WAS REPORTED, THERE WAS HEATING EXPERIENCED WHILE CHARGING THE IPG. THE EXACT MONTH AND DATE OF THE SYSTEM EXPLANT WAS UNKNOWN. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3332219

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT: