BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032287 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01353
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 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

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO 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 2 OF 2. REF MFR REPORT: 1627487-2013-1352. IT WAS REPORTED THE PT'S OCCIPITAL LEADS (OFF LABEL USE) ERODED THROUGH THE SKIN. THE PHYSICIAN REMOVED BOTH LEADS AND LEFT THE IPG IMPLANTED. THE PT WAS TREATED WITH ANTIBIOTICS, ALTHOUGH NO INFECTION WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130526 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3189 3498068

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788