BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850538 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-01347
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    September 16, 2009
    Report Date
    May 5, 2014
    Manufacturer
    ST. JUDE MEDICAL - 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT# 1627487-2014-01348. IT WAS REPORTED THE PT EXPERIENCED POCKET HEATING WHILE RECHARGING OVER THE LAST FEW YRS. REPORTEDLY, THE IPG SEEMS CLOSER TO THE SKIN SURFACE. SPACING WAS ADDED TO NO AVAIL. THE PT HAS GAINED WEIGHT SINCE IMPLANT. A REPLACEMENT CHARGER WAS SENT. F/U IDENTIFIED THE REPLACEMENT CHARGER IS WORKING PROPERLY AND THE ISSUE HAS RESOLVED. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. 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
    317421 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 50115

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other SCS LEAD: MODEL 3146| SCS ANCHOR: MODEL 1194| SCS LEAD: MODEL 3163| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE: