BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 22719459 · Received August 5, 2025

    Report

    Report Number
    1627487-2025-03868
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 3 COMPONENTS; HOWEVER, IT IS UNKNOWN WHICH COMPONENTS, THEREFORE ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8042800. COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8145643.

    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 THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN 2 DRG LEADS AND THE IPG WERE EXPLANTED. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE. WHEN ATTEMPTING TO EXPLANT THE RIGHT L2 LEAD THE LEAD WAS FRAGMENTED AND THE FRAGMENTED LEAD REMAINS IN THE PATIENT. SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE TO ADDRESS THE RIGHT L2 FRAGMENTED LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2643088 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8042800 05415067027153

    Patients

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