BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 23596709 · Received November 19, 2025

    Report

    Report Number
    1627487-2025-05714
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 19, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST 2 OF 4 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD; THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: S1: COMMON DEVICE NAME: KIT IMPLANTABLE SLIM TIP LEAD, 50CM, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7161025. T12: COMMON DEVICE NAME: KIT IMPLANTABLE SLIM TIP LEAD, 90CM, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7119085.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FOLLOWING A TRAUMATIC EVENT. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN TWO LEADS WERE CONFIRMED FRACTURED. AS A RESULT, THE TWO LEADS WERE EXPLANTED AND REPLACED. IT IS UNKNOWN WHICH LEADS WERE AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310151 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A 7119085 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG| DRG LEAD (X2)