BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110953 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-00253
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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
    AS
    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

    IT WAS REPORTED THAT A RECENT DIAGNOSIS TEST OF THE PT'S (AUSTRALIA) LEAD FOUND INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. REPROGRAMMING WAS UNDERTAKEN UTILIZING THE FUNCTIONING ELECTRODES RESULTING IN MARGINAL THERAPY COVERAGE FOR THE PT. AN X-RAY WAS TAKEN FOR FURTHER INTERROGATION. HOWEVER, NEITHER THE X-RAY RESULTS NOR THE DECISION REGARDING THE NEXT COURSE OF ACTION HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202208 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3517922

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788