BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 21118353 · Received January 9, 2025

    Report

    Report Number
    1627487-2025-00113
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 3, 2024
    Report Date
    January 23, 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

    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-DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 3 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: DRG LEAD, MODEL: MN10450-50A, UDI:(B)(4), SERIAL:(B)(6), BATCH: 10097675. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI:(B)(4), SERIAL:(B)(6), BATCH: 9242372.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO LEAD MIGRATION OF THE T10 LEAD AND WAS ABLE TO CONFIRM VIA X-RAY. IT WAS REPORTED THE LEAD EXHIBITED HIGH IMPEDANCES TOO. AS SUCH SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE T10 LEAD WAS REPLACED BUT THE OTHER T6 LEAD WAS UNABLE TO BE REPLACED DUE TO EXCESSIVE SCAR TISSUE AND AS SUCH EXPLANTED. ALONG WITH OTHER LEADS. THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376313 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 10097675 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other DRG IPG| DRG LEAD (2)