BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 21959404 · Received May 5, 2025

    Report

    Report Number
    1627487-2025-02156
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    February 28, 2025
    Report Date
    May 19, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: 50 CM IMPLANT LEAD KIT, SLIM TIP, 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR DRG SYSTEM. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE: IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE DRG SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469298 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8830818 05415067027153

    Patients

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