BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 7429686 · Received April 13, 2018

    Report

    Report Number
    3006705815-2018-00809
    Event Type
    Injury
    Date Received
    April 13, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#1627487-2018-03764. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW MODEL WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#1627487-2018-003764. IT WAS REPORTED THE PATIENT EXPERIENCED UNEXPECTED THERAPEUTIC EFFECTS IN THE RIGHT FLANK AREA. REPORTEDLY, REPROGRAMMING DID NOT PROVIDE RESOLUTION. X-RAYS HAVE BEEN ORDERED TO CONFIRM LEAD PLACEMENT. IN TURN, SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272844 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000039947

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192(2), SCS ANCHOR| MODEL 3662, SCS IPG