BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 23392073 · Received October 27, 2025

    Report

    Report Number
    1627487-2025-05269
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    October 9, 2025
    Report Date
    January 27, 2026
    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

    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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: KIT IMPLANTABLE SLIM TIP LEAD, 50CM, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9240021.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES ON ONE LEAD AND THE LEAD HAD MIGRATED. PATIENT LOST EFFECTIVE STIMULATION AS A RESULT. TO ADDRESS THE ISSUES, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2026 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAS HIGH IMPEDANCES ON ONE OF THE DRG LEADS. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734064 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9240021 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DRG IPG.