BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3979907 · Received July 24, 2014

    Report

    Report Number
    1627487-2014-21497
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS AND CONCLUSIONS: THE RETURNED PRODUCT WAS NOT ANALYZED FOR THE COMPLAINT OF LEAD MIGRATION AS LABORATORY TESTING CANNOT CONFIRM THE ALLEGATION. AS RECEIVED, THE OCTRODE LEAD HAD CHANNEL #7 OPEN. 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2014-021498. REFERENCE MFR REPORT: 1627487-2014-21499. IT WAS REPORTED THE PT ((B)(6)) WAS RECEIVING ONLY UNINTENDED LEFT LEG STIMULATION POST-OPERATIVELY. X-RAYS CONFIRMED THE LEAD HAD MIGRATED. SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION. PRE-OPERATIVE DIAGNOSTICS REVEALED ONE INVALID LEAD CONTACT. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTY STEERING THE NEW LEAD (DEVICE 2) TO THE DESIRED LOCATION; HOWEVER, AFTER SEVERAL REPOSITIONING ATTEMPTS, THE LEAD WAS IMPLANTED SUCCESSFULLY. FOLLOW-UP IDENTIFIED THE PT WAS RECEIVING STIMULATION IN THE DESIRED PAIN PATTERN; HOWEVER, THE AMPLITUDE WAS UNCOMFORTABLE FOR THE PT. DIAGNOSTICS REVEALED LOW LEAD IMPEDANCE CONTACTS (INCLUDING IPG AS DEVICE 3). THERE IS NO FURTHER INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434844 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other