BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 3850265 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-01316
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE MFR REPORT# 1627487-2014-013015. IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011. THE ORIGINAL IPG WAS EXPLANTED AND REPLACED FOR UNK REASONS. THE PT STATED HE EXPERIENCED POCKET HEATING SYMPTOMS. IT'S UNK IF THE ISSUE OCCURRED WHILE RECHARGING. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291638 CHARGING SYSTEM SCS CHARGING SYSTEM GZB ST. JUDE MEDICAL - NEUROMODULATION 3701 86288

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3214