BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17917596 · Received October 12, 2023

    Report

    Report Number
    1627487-2023-04876
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 11, 2023
    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

    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 SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8860742. 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 PATIENT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK DURING PERMANENT IMPLANT PROCEDURE WHILE THE PHYSICIAN WAS ATTEMPTING TO PLACE ONE LEAD. AS A RESULT, THE PROCEDURE WAS ABANDONED. A BLOOD PATCH WAS REQUIRED, AND PATIENT WAS LATER GIVEN IV FLUIDS ADMINISTERED WITH TYLENOL. PATIENT DID NOT REPORT ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284511 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8860742 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other