BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3821062 · Received May 9, 2014

    Report

    Report Number
    1627487-2014-00270
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE PATIENT (B)(6) IS A PARTICIPANT IN A CLINICAL STUDY. IT WAS REPORTED THE PATIENT EXPERIENCED PERFORATION OF THE LEFT LEAD. THIS ISSUE DID NOT IMPACT THE PATIENT'S THERAPY RELIEF. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 TO EXPLANT AND REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282303 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3183 3956298

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)