BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012165 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-13283
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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: 1627487-2013-13284. THE PT HAD TWO LEADS FROM DIFFERENT LOT NUMBERS, REPORTING ON BOTH. IT WAS REPORTED THE PT'S TRIAL LEADS WERE EXPLANTED DUE TO THE PT BEING DISSATISFIED WITH THE RESULTS THE SYSTEM WAS PROVIDING. THE PT STATED THE STIMULATION WAS NOT HELPING WITH HER PAIN. THE PT ALSO STATED HER ORIGINAL PAIN HAD GOTTEN WORSE AFTER THE LEADS WERE EXPLANTED. FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106498 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3831992

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention