BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 25119220 · Received May 7, 2026

    Report

    Report Number
    1627487-2026-02218
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027160
    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

    DATE OF EVENT IS ESTIMATED. D6B IS UNKNOWN. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND PATIENT INFORMATION. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: KIT IMPLANTABLE SLIM TIP LEAD, 90CM, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8041927.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY, SHOCKING, AND NUMBNESS. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480500 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A 8041927 05415067027160

    Patients

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