BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881144 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-15049
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    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

    IT WAS REPORTED THE PT'S STIMULATION WAS INEFFECTIVE. ALTHOUGH, IT WAS PREVIOUSLY REPORTED ADEQUATE STIMULATION WAS CAPTURED FOR THE PT VIA REPROGRAMMING, SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THE ISSUE. IT WAS REPORTED THE PT HAD EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 67289

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716