BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4113014 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-26746
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    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: 1627487-2014-26747. IT WAS REPORTED THE PT IS EXPERIENCING POCKET HEATING WHILE RECHARGING. A MODEL 3726 REPLACEMENT CHARGER WAS SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575194 EON SCS IPG GZB ST JUDE MED - NEUROMODULATION 3716 3834492

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other SCS LEAD, MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: