BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 23334007 · Received October 19, 2025

    Report

    Report Number
    1627487-2025-05129
    Event Type
    Injury
    Date Received
    October 19, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027160
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT RECEIVED A REPORT INDICATING THAT A PATIENT UNDERWENT AN EXPLANT OF THEIR CERVICAL DRG SYSTEM. DURING THE PROCEDURE, ONE OF THE LEADS WAS FOUND TO BE FRACTURED. AS A RESULT, THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR A FULL SYSTEM EXPLANT. THE INVESTIGATION RESULTS ARE INCONCLUSIVE, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THE ISSUE COULD NOT BE DETERMINED

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 3 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 SLIM TIP LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7011031. COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7597623. COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7597623.

    Description of Event or Problem · 0

    ADDITIONAL DETAILS INDICATE THAT DURING THE EXPLANT PROCEDURE, THE PHYSICIAN IDENTIFIED A FRACTURE IN ONE OF THE LEADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED WITHOUT COMPLICATION. IT IS UNKNOWN WHICH LEAD CONTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2738010 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A 6815511 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other DRG IPG| DRG LEAD X 3