BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2800881 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-11519
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 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. REF MFR REPORT: 1627487-2012-11518. IT WAS REPORTED THE PT HAD FALLEN, AND WAS NO LONGER FEELING THE STIMULATION. X-RAYS WERE TAKEN WHICH DID NOT REVEAL ANY ANOMALIES, AND THE IMPEDANCES FOR THE LEADS WERE WITHIN THE NORMAL RANGE. F/U IDENTIFIED THE PHYSICIAN MAY UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3183 2846375

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS EXTENSION: MODEL 3386| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| SCS ANCHOR: MODEL 1194| SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE: