BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 16272275 · Received January 31, 2023

    Report

    Report Number
    3006705815-2023-00400
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 2, 2023
    Report Date
    February 6, 2023
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCING LEAD MIGRATION WAS REPORTED TO ABBOTT. THE PATIENT LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 3006705815-2023-003978. IT WAS REPORTED THE PATIENT'S LEADS HAD MIGRATED. THE ISSUE WAS CONFIRMED VIA X-RAYS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 DURING WHICH THE EXISTING LEADS WERE EXPLANTED AND REPLACED. FOLLOWING THE PROCEDURE, THE PATIENT REPORTEDLY FELT PAIN IN THE GROIN DOWN TO THE FEET (MANUFACTURER REPORT NUMBER: 3006705815-2023-00401, 3006705815-2023-00402) AND THE LEADS WERE REMOVED DUE TO THE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895954 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000107320 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS ANCHORS X 2| SCS IPG