BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4093636 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-20191
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 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
    MI, 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 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 1 OF 2. REFERENCE MFR. REPORT: 1627487-2014-20192. IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT DUE TO POCKET HEATING WHILE CHARGING. A REPLACEMENT CHARGER WAS SHIPPED TO THE PATIENT. FOLLOW UP IDENTIFIED THE ISSUE HAS RESOLVED WITH THE NEW CHARGER. 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
    541621 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 4114752

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)| SCS LEAD: MODEL 3286| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186