BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 2852936 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-13121
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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 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

    IT WAS REPORTED THE PATIENT HAD PAIN AT HIS IPG SITE. THE PATIENT HAD LOST APPROXIMATELY 100 POUNDS AND IS REQUESTING A SMALLER IPG. FOLLOW-UP IDENTIFIED THE PATIENT IS SCHEDULED FOR ANOTHER SURGICAL PROCEDURE, DATE IS UNKNOWN AT THIS TIME. SURGICAL INTERVENTION FOR IPG REPLACEMENT IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 69567

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD, MODEL 3245| IMPLANT DATE: