BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2896222 · Received December 10, 2012

    Report

    Report Number
    1627487-2012-00804
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    DURING POST-OPERATIVE PROGRAMMING, IT WAS REPORTED THREE CONTACTS ON THE PATIENT'S (B)(6) LEAD DISPLAYED INVALID IMPEDANCE READINGS. AS A RESULT, THE PATIENT WAS UNABLE TO UTILIZE THE AFFECTED CONTACTS FOR THERAPY RELIEF. THE IMPEDANCE ISSUES WERE REPORTEDLY RESOLVED DURING A (B)(6) 2012 PROGRAMMING SESSION; HOWEVER, THE FOLLOWING DAY THE PATIENT CLAIMED THAT SHE IS AGAIN UNABLE TO ACHIEVE THERAPY FROM PROGRAMS WHICH UTILIZE TWO OF THE THREE CONTACTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3558127

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention