BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3821057 · Received May 7, 2014

    Report

    Report Number
    1627487-2014-15352
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT COULD NOT BE CONFIRMED. DIFFERENT LAB STYLETS ALSO WERE SUCCESSFULLY INSERTED INTO THE RETURNED LEAD AND RETRACTED NORMALLY, AND IT WAS POSSIBLE TO STEER THE LEAD WITHOUT ANY ISSUE. AS RECEIVED, THE LEAD WAS IN GOOD CONDITION WITHOUT ANY VISIBLE ANOMALIES. 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 THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 TO REPLACE A LEAD (REFERENCE MFR REPORT NUMBER: 1627487-2013-11673 AND 1627487-2014-05138). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO IMPLANT THE REPLACEMENT LEAD IN THE APPROPRIATE LOCATION. THE PHYSICIAN ABANDONED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276791 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3183 4327902

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788