BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3936143 · Received June 24, 2014

    Report

    Report Number
    1627487-2014-01414
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 2, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT# 1627487-2014-01415. IT WAS REPORTED THE PT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2014 EXPERIENCING LEG WEAKNESS. SUBSEQUENTLY, THE LEADS WERE EXPLANTED ON (B)(6) 2014 AND THE PT REMAINED HOSPITALIZED. FOLLOW-UP IDENTIFIED THERE WERE NO SIGNS OF INFECTION, HOWEVER, THE PT WAS GIVEN PROPHYLACTIC ANTIBIOTICS THROUGH A PICC LINE. FURTHER FOLLOW-UP REVEALED THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367200 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4444480

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention