BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2772005 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-10547
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: THE COMPLAINT REGARDING PT DISCOMFORT DUE TO THE SIZE OF THE IPG (SIZE RELATED) WAS NOT CONFIRMED. VISUAL INSPECTION OF THE IPG DID NOT REVEAL ANY ABNORMAL PHYSICAL CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. PER THE EVENT DETAILS, THE DISCOMFORT WAS RELATED TO THE PT'S WEIGHT LOSS. SJM HAS LIMITED INFO 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2012-10189. REFERENCE MFR REPORT: 1627487-2012-10190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3319791

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANT:| SCS LEAD EXTENSION: MODEL 3341| SCS LEAD EXTENSION: MODEL 3343| IMPLANT:| SCS LEAD ANCHOR: MODEL 1192 (2)| IMPLANT: