BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4142907 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-20248
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 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 INFO 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 3. REFERENCE MFR REPORT# : 1627487-2014-20249, 1627487-2014-20252. IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS DETERMINED INVALID AND LOW IMPEDANCES ON THE LEAD. X-RAYS DID NOT REVEAL ANY ANOMALIES. THE SJM REP WAS UNABLE TO CAPTURE THE LOWER BACK PAIN. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590854 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3599434

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL, 1192(2)