BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5067716 · Received September 10, 2015

    Report

    Report Number
    3004209178-2015-17685
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N521822, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE IN REGARD TO A PATIENT RECEIVING DILAUDID 0.5 MG/ML AT 0.025 MG/DAY VIA AN IMPLANTABLE INFUSION PUMP. THE PATIENT HAD A RETURN OF ORIGINAL PAIN SINCE THE BEGINNING OF JULY. THE PATIENT DENIED INCITING INCIDENT OR TRAUMA. THE PUMP WAS PALPABLY FLIPPING WITHIN POCKET, SUGGESTING POSSIBLE KINKING OF THE CATHETER. THE PATIENT DENIED ANY IMPROVEMENT OR WORSENING OF PAIN ("SUGGESTING KINKING OR U KINKING OF CATHETER") WITH POSITION CHANGE OR ACTIVITY AND REPORTED THE PTM BOLUSES WERE NO LONGER EFFECTIVE PRIOR TO JULY. ON (B)(6) 2015, A CAP (CATHETER ACCESS PORT) ASPIRATION INTRA-OP WAS DONE AFTER THE PUMP WAS REMOVED FROM POCKET WHICH REVEALED GOOD RETURN OF CSF (CEREBROSPINAL FLUID) AND NO VISIBLE KINK OR CATHETER DEFECT WAS IDENTIFIED, SO THE CATHETER WAS RE-COILED BEHIND PUMP AND MESH POUCH RE-ANCHORED TO ADIPOSE TISSUE AS THEY COULD NOT ANCHOR TO FASCIA DUE TO BODY HABITUS. SURGICAL REPOSITIONING AND ANCHORING OF THE PUMP WITH THE POCKET OCCURRED ON (B)(6) 2015. NO OTHER DIAGNOSTICS WERE NEEDED, BECAUSE THE PUMP WAS EASILY ABLE TO BE FLIPPED. THE PUMP WAS EMPTIED OF 23 ML DILAUDID 0.5 ML (EXPECTED VOLUME) AND FILLED WITH NEW DILAUDID 0.5 MG/ML 40 ML. SIMPLE CONTINUOUS WAS DECREASED FROM 0.05 MG/DAY TO 0.025 MG/DAY. THE PA (PHYSICIAN ADMINISTERED) DOSING CHANGED FROM 0.013 MG Q 1HR X 4 TO 0.025 MG Q 2HRS. X 10. THE ISSUE WAS REPORTEDLY RESOLVED. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE - NO INJURY.

    Description of Event or Problem · 1

    ON 2015-09-29, ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE. IT WAS REPORTED THAT THE MANAGING PHYSICIAN HAD REPORTED THE EVENT TO THE COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599091 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention