BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 21773309 · Received April 4, 2025

    Report

    Report Number
    1627487-2025-01620
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 4, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067025548
    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

    THE DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST 1 OF 4 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: MN10450-90A, UDI: (B)(4), BATCH: AB2450. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-90A, UDI: (B)(4), BATCH: AB2440. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6151578.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE DRG SYSTEM. AS A RESULT, SURGICAL INTERVENTION ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302264 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A AB2284 05415067025548

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG.| DRG LEAD (X3).