BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 17923919 · Received October 12, 2023

    Report

    Report Number
    3006705815-2023-06566
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    August 10, 2023
    Report Date
    February 26, 2024
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    PRODUCT #1 PI MAIN [PI-2023-0132044-01] A PATIENT EXPERIENCED LEAD MIGRATION WAS REPORTED TO ABBOTT. NO PROCEDURE WAS NOT PERFORMED TODAY DUE TO PT BEING IN A. FIB WITH RVR. PROCEDURE NOT BEING RESCHEDULED AT THIS TIME DUE TO HEALTH COMPLICATIONS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED. SURGICAL INTERVENTION TOOK PLACE WHERE THE PATIENTS LEADS WERE EXPLANTED AND REPLACED. RELATED MANUFACTURING REPORT: 3006705815-2023-06568.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285891 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000127961 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS ANCHOR (X2)| SCS IPG