BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3142218 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-00280
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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 DEVICE MODEL IS ASSOCIATED WITH A FIELD CORRECTION. CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS WERE PERFORMED. EVALUATION RESULTS: POCKET HEATING 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 # 1627487-2013-00279. IT WAS REPORTED THE RECHARGING TIME FOR THE PATIENT'S IPG HAS INCREASED FROM ONE HOUR TO FOUR HOURS. IN ADDITION, THE PATIENT REPORTED EXPERIENCING UNCOMFORTABLE WARMTH AT THE IPG POCKET WHEN RECHARGING. TO MINIMIZE THE DISCOMFORT, THE PATIENT REPORTEDLY RECHARGES IN INCREMENTS. A LOW-ENERGY CHARGING SYSTEM HAS BEEN SHIPPED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235966 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3350790

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS LEAD, MODEL: 3219| IMPLANT DATE: