BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 16413898 · Received February 21, 2023

    Report

    Report Number
    1627487-2023-00604
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401708
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST 1OF 2 COMPONENTS; HOWEVER, IT IS UNKNOWN WHICH COMPONENT(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE, MODEL: 3186, UDI: (B)(4), SERIAL: N/A, BATCH: 3920599.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEAD SHOWED HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED DUE TO NORMAL DEPLETION AND THE LEAD HAD ONE CONTACT STILL HAD IMPEDANCE. PHYSICIAN MADE A DECISION NOT TO REPLACE LEAD DUE TO SCAR TISSUE. EFFECTIVE THERAPY RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676733 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 3920599 05414734401708

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS ANCHORX2| SCS IPG