BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2921645 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-12057
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 REPORT # 1627487-2013-12056 AND 1627487-2013-12058. IT WAS REPORTED THE PATIENT HAS AN MRI SCHEDULED. THE PHYSICIAN ASKED THE SJM REPRESENTATIVE ABOUT SAFETY CONCERNS WITH AN MRI BECAUSE THE PATIENT HAS LEADS IMPLANTED. FOLLOW-UP DETERMINED THE PHYSICIAN PLANS TO EXPLANT THE LEAD PRIOR TO THE MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13964 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3161 117771

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R IMPLANT DATE:| SCS EXTENSION: MODEL 3343| IMPLANT DATE:| SCS ANCHOR: MODEL: 1194 (2)