BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4093626 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-01569
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 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

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT EXPERIENCED INEFFECTIVE COVERAGE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN. THE SCS SYSTEM WAS EXPLANTED. FOLLOW-UP IDENTIFIED THE PROCEDURE WENT WITHOUT INCIDENT AND THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542133 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4046651

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3788