BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2903212 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-00007
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    October 7, 2011
    Report Date
    December 5, 2012
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 1 OF 2. REFERENCE MFR REPORT# 1627487-2013-00008. THE PT'S ((B)(6)) THERAPY SYSTEM INCLUDES TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE ONE OF THE DEVICES. THIS INFO WAS DISCOVERED BY THE MFR AFTER REVIEWING THE PATIENT'S FILES. THE REASON FOR THE PROCEDURE IS UNK. SINCE IT IS NOT KNOWN WHICH LEAD WAS REPLACED, BOTH LOTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION 3186 2801980

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788