BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 14857565 · Received June 29, 2022

    Report

    Report Number
    1627487-2022-03656
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    June 10, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD , MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7023280. 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. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE AND EVENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENTS LEAD HAD MIGRATED. MIGRATION CONFIRMED VIA X-RAY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT IS IMPLANTED WITH 2 LEADS, THE INVESTIGATION DID NOT DETERMINE WHICH LEAD WAS MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472816 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 7085686 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other