BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 23990061 · Received January 7, 2026

    Report

    Report Number
    1627487-2026-00089
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 10, 2025
    Report Date
    April 17, 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: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982304. COMMON DEVICE NAME: DRG LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982304.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT LOST EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT'S L3 AND L4 DRG LEADS HAD HIGH IMPEDANCES. PATIENT LOST EFFECTIVE THERAPY AS A RESULT. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUES. THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68965 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7982304 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other DRG IPG| DRG LEAD 2X