BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3010550 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01274
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 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

    RESULTS: THE COMPLAINT FOR "PATIENT DISCOMFORT" FOR RETURNED OCTRODE LEAD WAS NOT CONFIRMED. THE COMPLAINT CANNOT BE ANALYZED THROUGH PRODUCT ANALYSIS ALONE. AS RECEIVED, MICROSCOPIC INSPECTION REVEALED THE LEAD WAS IN GOOD CONDITION. THE LEAD PASSED ALL FUNCTIONAL AND CONTINUITY TESTING. SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PATIENT'S 3189 PERIPHERAL OCTRODE LEAD WAS EXPLANTED AND REPLACED WITH TWO (OFF LABEL) WIDE-SPACED QUATTRODES BECAUSE THE PATIENT WAS FEELING A PINCHING SENSATION AT THE LEAD SITE WHEN STIMULATION WAS ON. THE ISSUE IS NOW RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108282 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3787675

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3186| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1192| IMPLANT DATE: