BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3701810 · Received February 24, 2014

    Report

    Report Number
    1627487-2014-05155
    Event Type
    Injury
    Date Received
    February 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 30, 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 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. REFERENCE MFR REPORT#: 1627487-2014-051554 IT WAS REPORTED THE PT IS NOT RECEIVING ADEQUATE COVERAGE. IT WAS ALSO REPORTED THE PT IS RECEIVING STIMULATION IN UNINTENDED AREAS. REPROGRAMMING TO PROVIDE RESOLUTION WAS UNSUCCESSFUL. THE PT IS ALSO EXPERIENCING OVERSTIMULATION. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. THE PT WILL UNDERGO X-RAYS FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114738 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 113545

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (X2)