BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3962547 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-15540
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 8, 2012
    Report Date
    June 23, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 2. REFERENCE MFR REPORT: 1627487-2014-15539. THE PATIENT REPORTED HE HAS EXPERIENCED UNCOMFORTABLE HEATING AT THE IPG SITE WHILE CHARGING SINCE HIS IPG WAS IMPLANTED. THE PATIENT CHARGES FOR APPROXIMATELY 7 HOURS EVERYDAY, USES THE CHARGING POUCH AND AT TIMES PLACES A TOWEL BETWEEN THE CHARGER AND HIS SKIN. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT, HOWEVER THE ISSUE PERSISTS. THE PATIENT STATED HE IS NOT BOTHERED BY THE HEATING AND DOES NOT WISH TO PURSUE ANY FURTHER INTERVENTION FOR THIS MATTER. 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
    409718 CHARGING SYSTEM SCS CHARGING SYSTEM GZB ST JUDE MED - NEUROMODULATION 3701 57031

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS LEAD, MODEL 3288| IMPLANT: