BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4132671 · Received September 24, 2014

    Report

    Report Number
    1627487-2014-03630
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    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
    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

    THE PATIENT HAS 2 SCS LEADS WITH THE FROM THE SAME LOT. IT WAS REPORTED THE PATIENT IS EXPERIENCING DIFFICULTY WALKING. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED A FALL AND COMPLICATIONS FROM HIP SURGERY PRIOR TO THIS ISSUE. THE SCS SYSTEM IS TO BE EXPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595990 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4349932

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other IMPLANT DATE:| SCS IPG: MODEL 3716