BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3412535 · Received October 8, 2013

    Report

    Report Number
    1627487-2013-21129
    Event Type
    Injury
    Date Received
    October 8, 2013
    Date of Event
    September 12, 2013
    Report Date
    September 17, 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 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 1 OF 3. REFERENCE MFR. REPORT: 1627487-2013-021130, REFERENCE MFR. REPORT: 1627487-2013-021131. IT WAS REPORTED THE PT HAD THE SCS LEADS EXPLANTED AND REPLACED DUE TO INEFFECTIVE STIMULATION. REPROGRAMMING WAS UNSUCCESSFUL PRIOR TO THE SURGICAL INTERVENTION. IT WAS ALSO REPORTED THE IPG WAS ELECTIVELY REPLACED. THE PT HAS EFFECTIVE STIMULATION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508314 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3186 2751895

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL: 1194 (3)| SCS IPG: MODEL: 3788| IMPLANT DATE:| SCS EXTENSION: MODEL: UNK