BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2871472 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-02759
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    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 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 THE PATIENT ONLY FELT STIMULATION IN HER BACK AND X-RAYS REVEALED THE LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS SCHEDULED TO ADDRESS THE ISSUE. FOLLOW-UP IDENTIFIED THE PATIENT HAD A STROKE AND SURGERY WAS POSTPONED. IT WAS REPORTED THE PATIENT'S STROKE WAS UNRELATED TO HER SCS SYSTEM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 47278

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS IPG, MODEL 3688| IMPLANT DATE: