BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4201989 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-26861
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    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

    (B)(4). 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 PT WAS IMPLANTED WITH A SCS SYSTEM WHICH INCLUDES TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT EXPERIENCED AUTO-REDUCING. REPROGRAMMING INITIALLY RESOLVED THE ISSUE. FOLLOW UP INFO IDENTIFIED REPROGRAMMING IS NOW UNABLE TO RESOLVE THE ISSUE. LEAD DIAGNOSTICS SHOWED NO ANOMALIES NOW AS THE SJM REP IS NOW ABLE TO USE A COMPATIBLE DEVICE. AN X-RAY WAS TAKEN AND SHOWED NO ANOMALIES. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663346 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4541121

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| SCS IPG, MODEL 3789,| SCS ANCHOR, MODEL 1192 (2),| IMPLANT DATE: