BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5181821 · Received October 27, 2015

    Report

    Report Number
    1627487-2015-26565
    Event Type
    Injury
    Date Received
    October 27, 2015
    Date of Event
    June 1, 2015
    Report Date
    November 4, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    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

    DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2015-26566. SINCE WE ARE UNABLE TO DETERMINE WHICH LEAD IS THE RIGHT LEAD, WE ARE REPORTING ON BOTH POSSIBLE LEADS. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION ON HER RIGHT SIDE. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAY'S WERE TAKEN AND SHOWED THE RIGHT LEAD HAS MIGRATED. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. EXACT DATE OF EVENT IS UNLNOWN, HENCE DATE IS APPROXIMATED.

    Description of Event or Problem · 1

    DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2015-26566. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE ORIGINAL LEADS AND IMPLANT THE NEW LEADS OVER THE OCCIPITAL NERVE WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712232 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3550904

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other