BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2926112 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-01078
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    REFERENCE MFR REPORT: 1627487-2013-1079. IT WAS REPORTED, THE PATIENT IS NOT RECEIVING STIMULATION. A SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED ALL CONTACTS WERE INVALID. X-RAYS WERE ORDERED AND THE PATIENT IS PENDING FOLLOW UP WITH HER SURGEON. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25423 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3286249

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)