BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 16034380 · Received December 22, 2022

    Report

    Report Number
    1627487-2022-07001
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    December 7, 2022
    Report Date
    December 22, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. EXACT DATE OF EVENT IS UNKNOWN. THE ALLEGATION IS AGAINST 1 OF 2 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), SERIAL: (B)(4), BATCH: 7101314.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED NERVE STIMULATION WITH THEIR CERVICAL SYSTEM. IT IS UNCLEAR WHICH LEAD CONTRIBUTED TO THIS ISSUE. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2022 DURING WHICH THE PATIENT'S ENTIRE CERVICAL SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841305 OCTRODE LEAD KIT, 90CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3189 7101314 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHOR (X2)| SCS IPG| SCS LEAD