BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 22168556 · Received June 9, 2025

    Report

    Report Number
    1627487-2025-02801
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    June 2, 2025
    Report Date
    June 9, 2025
    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. 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. 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: 50CM SLIMTIP IMPLANT LEAD KIT, ABT, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8830818.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF ONE DRG LEAD. X-RAY IMAGING WAS USED TO CONFIRM THE MIGRATION. TO ADDRESS THE ISSUE, THE LEAD WAS REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2025. THERAPY WAS RESTORED POST OP. IT IS UNKNOWN WHICH LED CAUSED/CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631204 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8830818 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Male Other DRG IPG| DRG LEAD