BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850256 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-01311
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 22, 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 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

    THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT IS REPORTED THE PT EXPERIENCED OVERSTIMULATION AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE LEADS WERE FOUND TO BE COILED BELOW THE IPG. THE PHYSICIAN BELIEVED THIS MAY HAVE CONTRIBUTED TO THE ISSUE. THE LEADS WERE EXPLANTED AND REPLACED. THE IPG WAS ALSO EXPLANTED AND REPLACED DURING THIS SAME PROCEDURE. PLEASE REFERENCE MFR REPORT# 1627487-2014-04178 REGARDING THE IPG. FOLLOW-UP EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY AND THE ISSUE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291636 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 65069

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS IPG: MODEL 3716| IMPLANT DATE: