BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 25338372 · Received May 29, 2026

    Report

    Report Number
    1627487-2026-08147
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 15, 2026
    Report Date
    May 29, 2026
    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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8060953. COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8070384. COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8070384. 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 DURING A SYSTEM EXPLANT PROCEDURE ON (B)(6) 2026 ONE OF THE CONTACTS ON A LEAD BROKE AND REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD'S CONTACT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271188 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8060953 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1