BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 12636213 · Received October 14, 2021

    Report

    Report Number
    1627487-2021-17680
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. A PATIENT EXPERIENCING INEFFECTIVE STIMULATION DUE TO 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 · 1

    RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-17679, 1627487-2021-17678. IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEADS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530158 OCTRODE LEAD KIT, 90CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3189 6943944 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other