BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012196 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-15350
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    May 1, 2010
    Report Date
    February 20, 2013
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15351. THE PATIENT HAD 2 LEADS (FROM THE SAME LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED, THE PATIENT'S SCS SYSTEM WAS EXPLANTED BECAUSE, IT WAS NOT RELIEVING HER PAIN. ADDITIONALLY, THE STIMULATION WAS PAINFUL FOR THE PATIENT WHENEVER IT WAS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106160 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2841261

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: