BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRG SLIM TIP LEAD

    MDR report key: 22202973 · Received June 13, 2025

    Report

    Report Number
    1627487-2025-02923
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    July 18, 2024
    Report Date
    March 19, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT, AND DEVICE INFORMATION. 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.

    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.

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT, AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 0

    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 SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8081987. COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8081987. COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8081987.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO HIGH IMPEDANCES ON ONE LEAD. IT IS UNKNOWN WHICH LEAD WAS AT FAULT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS FRACTURED AND LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345018 DRG SLIM TIP LEAD DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8081987 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other (B)(6) LEAD.