BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 14751117 · Received June 21, 2022

    Report

    Report Number
    1627487-2022-03454
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 20, 2022
    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. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: COMMON DEVICE NAME: SCS LEAD, MODEL: 3189, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7101314. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY ON ONE SIDE DUE TO HIGH IMPEDANCE ON THE LEFT LEAD. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP. NOTE: IT IS UNKNOWN WHICH SN IS THE LEFT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350675 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 7045438 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other SCS IPG