BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 17283584 · Received July 7, 2023

    Report

    Report Number
    1627487-2023-03155
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    February 28, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: UNKNOWN , LOT: 3062371.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED THAT THE LEAD HAD MULTIPLE CONTACTS WITH HIGH IMPEDANCE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IEAD WAS EXPLANTED BUT PHYSICIAN WAS UNABLE TO IMPLANT NEW LEAD TO SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677906 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 3062371 05415067017246

    Patients

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