BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 23699679 · Received December 2, 2025

    Report

    Report Number
    1627487-2025-05918
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    October 13, 2025
    Report Date
    May 11, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH:8830818.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT'S SYSTEM WAS AUTOREDUCING DUE TO HIGH IMPEDANCES ON ONE OF THE LEADS. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. PATIENT LOST EFFECTIVE THERAPY AS A RESULT. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2026 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350782 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8830818 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other DRG IPG| DRG LEAD