BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 16583384 · Received March 21, 2023

    Report

    Report Number
    1627487-2023-01089
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    August 26, 2022
    Report Date
    March 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 3 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3189, UDI:(B)(4) , BATCH: 4340795. COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3189, UDI:(B)(4), BATCH: 4210954. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE DOCUMENTS REVIEWED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S IPG IS INOPERABLE AND ONE OF THE LEADS WAS FRACTURED. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG AND ONE LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356279 OCTRODE LEAD KIT, 90CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3189 3983034 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHORS X 2