BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 19544755 · Received June 16, 2024

    Report

    Report Number
    1627487-2024-09346
    Event Type
    Injury
    Date Received
    June 16, 2024
    Date of Event
    March 7, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, IT COULD NOT BE DETERMINED IF THE LEAD CONTRIBUTED TO THE REPORTED ISSSUE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6183666.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE SCS SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED DUE TO SYSTEM NO LONGER PROVIDING ADEQUATE RELIEF. SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937538 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 6183666 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS LEAD