BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133383 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-05699
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 23, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 HAD TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT EXPERIENCED OVERSTIMULATION WHEN SHE ATTEMPTED TO INCREASE STIMULATION. LOW IMPEDANCE WAS FOUND ON SEVERAL CONTACTS. X-RAYS REVEALED NO ANOMALIES. AS A RESULT, THE LEADS WERE EXPLANTED AND REPLACED. THE REPLACEMENT LEADS RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223413 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 175684

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCS ANCHOR: MODEL 1194(X2)| SCS IPG: MODEL 3788| IMPLANT:| IMPLANT: