BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 3955668 · Received July 24, 2014

    Report

    Report Number
    3007566237-2014-02073
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703W, LOT# L34868, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING NO PAIN RELIEF. THE HCP (HEALTH CARE PROFESSIONAL) ATTEMPTED TO DO A CAP (CATHETER ACCESS PORT) DYE STUDY, BUT WAS UNABLE TO ASPIRATE THE CATHETER. THEY WERE PLANNING TO REVISE THE CATHETER. IT WAS LATER REPORTED THAT THERE WAS A FRACTURE IN THE PUMP POCKET PORTION OF THE CATHETER. THE PUMP WAS REPLACED AND A NEW PUMP CONNECTOR PIECE WAS USED; PER THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE NEW PUMP CONNECTOR WAS ATTACHED TO THE EXISTING CATHETER. THE DEVICE SYSTEM WAS DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434741 ISOMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8472-60-05

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention