BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 16663284 · Received April 3, 2023

    Report

    Report Number
    1627487-2023-01465
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    January 7, 2023
    Report Date
    April 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734402231
    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

    CORRECTED DATA: PATIENT WEIGHT UPDATED TO REFLECT ESTIMATED WEIGHT AT TIME OF SURGICAL INTERVENTION. 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE TRIAL LEAD KIT, 60CM LENGTH, MODEL: 3186ANS, UDI: (B)(4), SERIAL: (B)(4), BATCH: 5232957.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-01963. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION AND THE IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN IN WHICH THE IPG AND THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878811 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS PADDLE LEAD LGW ABBOTT MEDICAL 3286 5037080 05414734402231

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SCS LEAD (X1)| SCS LEAD ANCHOR (X2)