BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 22307868 · Received June 23, 2025

    Report

    Report Number
    1627487-2025-03058
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 28, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9042817.

    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 THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON ONE LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970385 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8904026 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other DRG IPG| DRG LEAD