BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141412 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-03720
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES: RESULTS- THE EVENT WAS NOT CONFIRMED THROUGH PRODUCT ANALYSIS TESTING. THE 3186 LEAD WAS NOT ELECTRICALLY TESTED DUE TO THE EXPLANT DAMAGE. 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. REFERENCE MFR REPORT: 1627487-2013-03508.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231098 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3186 3863050

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention IMPLANT DATE:| SS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS IPG: MODEL 3788