BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960667 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-21496
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    February 4, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REF MFR REPORT: 1627487-2014-21495. IT WAS REPORTED, THE PT'S ((B)(6)) RIGHT OCCIPITAL LEAD WAS SUPERFICIAL AND MAY HAVE ERODED THROUGH THE SKIN (NOT CONFIRMED). THE PT ALSO RECEIVED INEFFECTIVE STIMULATION; HOWEVER, THE SJM REP WAS ABLE TO PROVIDE INCREASED COVERAGE VIA REPROGRAMMING. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424022 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4155066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANT DATE:| SCS IPG: MODEL 3788