BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792063 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-11486
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 19, 2012
    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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-11485. IT WAS REPORTED THE PT RECEIVED TWO TRIAL LEADS, AND REPORTED URINARY FREQUENCY AND AN ISSUE REGARDING HER LEFT LEG LOCKING UP, WHICH WAS CAUSING HER TO FALL. THE PHYSICIAN REMOVED TO TRIAL LEADS. IT WAS REPORTED THE PT HAD A SUTURE REMOVED AT A LATER DATE WHICH CAUSED THE PT DISCOMFORT. F/U IDENTIFIED THE PT HAD BEEN HOSPITALIZED DUE TO A BLOOD CLOT IN HER LEFT LEG ON (B)(6) 2012. FURTHER F/U IDENTIFIED THE PT HAD BEEN DISCHARGED FROM THE HOSPITAL AND WAS RECEIVING COUMADIN SHOTS TO ADDRESS THE CLOT. IT WAS REPORTED THE PT HAD AN INFECTION IN HER KNEE DUE TO INJECTIONS FROM AN ORTHOPEDIC PHYSICIAN. THE PT WAS NOT SCHEDULED WITH HER IMPLANTING PHYSICIAN DUE TO OTHER PHYSICIAN APPOINTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS TRIAL LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3689111

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R