BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOCTRODE

    MDR report key: 3890746 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-10125
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 9, 2013
    Report Date
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT (B)(6) IS A PARTICIPANT IN A CLINICAL STUDY. IT WAS REPORTED THE PT PRESENTED TO THE EMERGENCY ROOM WITH A MIGRAINE HEADACHE. THE PHYSICIAN OBSERVED THE PT'S SCS LEAD WAS PROTRUDING. THE PT'S LEAD WAS EXPLANTED. F/U ON THIS MATTER IDENTIFIED A NEW LEAD WAS IMPLANTED ON (B)(6) 2013. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324407 IOCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3902507

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANT DATE: UNK| SCS LEAD ANCHOR: MODEL 1194 (2)| SCS LEAD EXTENSIONS: MODEL 3386 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: UNK