BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 21416988 · Received February 19, 2025

    Report

    Report Number
    1627487-2025-00819
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. 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: 7982307.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED. THE INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025, IN WHICH THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190296 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7982307 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other DRG IPG| DRG LEAD