BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3052233 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-00200
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE MODEL IS ASSOCIATED WITH A FIELD CORRECTION. DEVICE EVALUATED BY MANUFACTURER: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS 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 #1627487-2013-00199. IT WAS REPORTED THE PATIENT (B)(6) AT TIMES EXPERIENCES HEATING AT THE IPG POCKET AFTER RECHARGING. THE REPORTED DISCOMFORT REPORTEDLY LAST SOMETIMES UP TO THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139538 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2852615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANT DATE:| SCS LEAD, MODEL: 3228