BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3052366 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-04402
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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 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: 1627487-2013-04403. IT WAS REPORTED THE PATIENT HAD RECEIVED NOTICE TO HAVE THE CHARGING SYSTEM REPLACED. THE PATIENT REPORTED SHE HAD EXPERIENCED POCKET HEATING WHILE RECHARGING AND THE PHYSICIAN HAD EXPLANTED THE SCS SYSTEM IN (B)(6) OF 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137385 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 115832

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS EXTENSION: MODEL 3341 (2)| IMPLANT:| SCS LEAD: MODEL 3166 (4)| IMPLANT: