BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950312 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-01405
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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
    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

    DEVICE 2 OF 2. REFER TO MFR REPORT 1627487-2014-01404. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION IN THE LOWER LEFT EXTREMITIES. FOLLOW UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014. THE PHYSICIAN OPTED TO EXPLANT THE ENTIRE SCS SYSTEM BECAUSE THE PATIENT WAS UNABLE TO RECEIVE THE DESIRED PARESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360872 OCTRODE GZB ST JUDE MEDICAL NEUROMODULATION 3186 3346017

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other SCS ANCHOR: MODEL 1192 (2),| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788,