BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18387093 · Received December 22, 2023

    Report

    Report Number
    1627487-2023-06100
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    December 5, 2023
    Report Date
    January 20, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO ABBOTT, A PATIENT UNDERWENT A LEAD REVISION DUE TO HAVING A SUSPECTED LEAD FRACTURE FOLLOWING A FALL. DURING THE PROCEDURE THE SUSPECTED LEAD WAS REPLACED. ADDITIONALLY, THE PATIENT EXPERIENCED A CSF LEAK. A CT SCAN WAS UNDERTAKEN WITH NO NOTED ABNORMALITIES AND A BLOOD PATCH WAS PERFORMED TO ADDRESS THE ISSUE. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    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: 9202264.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER:1627487-2023-06099. IT WAS REPORTED THAT DURING A LEAD REPLACEMENT SURGERY ON (B)(6) 2023 THE PATIENT EXPERIENCED A DURAL PUNCTURE. ON (B)(6) 2023 THE PATIENT REPORTED EXPERIENCING SPINAL HEADACHES. A CT SCAN WAS UNDERTAKEN WITH NO NOTED ABNORMALITIES AND A BLOOD PATCH WAS PERFORMED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298086 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9240045 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG (X1)| DRG LEAD (X1)