BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961295 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-24034
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 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

    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

    DEVICE 1 OF 6. REFERENCE MFR REPORTS: 1627487-2014-24035, 1627487-2014-24036, 1627487-2014-24037, 1627487-2014-24038, 1627487-2014-24039. PATIENT RECEIVED TWO 3189 LEADS WITH THE SAME LOT NUMBER (4245741). IT WAS REPORTED ONE OF THE PATIENT'S PERIPHERAL (OFF-LABEL) LEAD TIPS ERODED THROUGH HER SCALP. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 TO REPOSITION THE LEAD. EFFECTIVE STIMULATION WAS RESTORED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421082 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 4245741

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3346| SCS EXTENSION: MODEL 3343(2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS IPG: MODEL 3716