BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDA

    MDR report key: 13795713 · Received March 17, 2022

    Report

    Report Number
    3004209178-2022-03403
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    March 13, 2022
    Report Date
    March 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000051129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-40, LOT#: NGV733732H (B)(4), IMPLANTED: (B)(6) 2022, EXPLANTED: (B)(6) 2022, PRODUCT TYPE :PUMP; PRODUCT ID: 8637-40, LOT#: NGV733732H, IMPLANTED: (B)(6) 2022, EXPLANTED: (B)(6) 2022, PRODUCT TYPE: PUMP. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8637-40, SERIAL/LOT #: (B)(4), UBD: 28-APR-2023, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT VIA HEALTHCARE PROVIDER WHO WAS RECEIVING MORPHINE (5MG/ML AT .55 MG/ML) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT ST. VINCENT WITH COMPLAINTS RELATED TO CEREBRA SPINAL FLUID (CSF) LEAK. THE HEALTHCARE PROVIDER REMOVED OLD CATHETER AND REPLACED WITH A NEW 8781 CATHETER. PATIENTS DOG JUMPED ON HER. ENVIRONMENTAL FACTORS THAT HAVE LED TO THE ISSUE WAS THE PATIENT'S DOG JUMPED ON HER. THE ISSUE WAS RESOLVED AT TIME OF THE REPORT. PATIENT STATUS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16109 ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8781 00763000051129

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention