BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202478 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-15775
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 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 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

    DEVICE 1 OF 2 REFERENCE MFR REPORT#: 1627487-2014-15776. IT WAS REPORTED ONE OF THE PATIENT'S LEADS WAS AUTO-REDUCING. DIAGNOSTICS INDICATED IMPEDANCE READINGS WITHIN NORMAL LIMITS. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE. IT IS UNKNOWN WHICH LEAD IS AUTO-REDUCING; THEREFORE ALL POSSIBLE LOTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669403 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3234936

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT:| IMPLANT: