BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 21440070 · Received February 21, 2025

    Report

    Report Number
    1627487-2025-00853
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    November 18, 2024
    Report Date
    February 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7161036.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-00856. IT WAS REPORTED PATIENT WAS UNABLE TO ENTER MRI MODE AND THE DRG SYSTEM WAS AUTO-REDUCING. DIAGNOSTICS SHOWED ONE OF THE T12 LEADS HAD LOW IMPEDANCES AND L1 AND L2 LEADS HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THREE LEADS AND IPG WERE EXPLANTED TO ADDRESS THE ISSUE. HOWEVER, THE L1 LEAD WAS BROKEN DURING THE PROCEDURE AND PARTIALLY IMPLANTED. THERAPY WAS RESTORED WITH THE FUNCTIONAL T-12 LEAD POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045524 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7113424 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other DRG IPG| DRG LEAD