BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18731098 · Received February 19, 2024

    Report

    Report Number
    1627487-2024-00819
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    January 30, 2024
    Report Date
    March 7, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A PRODUCT 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

    THE DATE OF EVENT IS ESTIMATED. 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: DRG LEAD, MODEL: MN10450-50A, UDI:(B)(4), SERIAL: (B)(6), BATCH: 8060953.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT L5 LEAD HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHERE THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS IS THE RIGHT L5 LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416568 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7974144 05415067027153

    Patients

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