BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4252648 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-24350
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 17, 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: 1627487-2014-24355. IT WAS REPORTED THE PT DESIRED TO HAVE HER SCS SYSTEM EXPLANTED. SURGICAL INTERVENTION TOOK PLACE TO EXPLANT THE SCS SYSTEM. THE REASON FOR THE EXPLANT IS INEFFECTIVE PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710203 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3345989

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other SCS ANCHOR: MODEL 1192(2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788