BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 20761616 · Received November 22, 2024

    Report

    Report Number
    1627487-2024-12124
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    October 28, 2024
    Report Date
    March 27, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE NUMBER- (B)(6). DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI:(B)(4), SERIAL: (B)(6), BATCH: 7023267

    Additional Manufacturer Narrative · 0

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEAD HAS ALL LOW IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEADS WERE EXPLANTED AND REPLACED WITH A PENTA LEAD TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777794 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 6888889 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other