BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2903198 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-00018
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    June 1, 2009
    Report Date
    December 7, 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
    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

    IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) 2009 TO ADDRESS A LEAD MIGRATION ISSUE. THE LEAD IN QUESTION WAS PLACED IN THE OCCIPITAL REGION (OFF-LABEL) AND MIGRATION HAD BEEN CONFIRMED TWO MONTHS PRIOR VIA X-RAY. THE X-RAY ALSO SUGGESTED A CUT IN THE LEAD. IN ADDITION, THE PATIENT COMPLAINED OF DISCOMFORT AT THE BACK OF THE HEAD AS WELL AS DISCOMFORT AT THE IPG SITE. THE (B)(6) 2009 PROCEDURE (EXACT DATE UNK) WAS COMPLETED WITH THE IMPLANT OF TWO ADD'L PERCUTANEOUS LEADS. NO FURTHER INFO REGARDING THIS EVENT IS AVAILABLE. REFERENCE MFR REPORT #: 1627487-2013-00016 FOR THE INITIAL REPORT OF IPG DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION 3186 67983

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention