BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4180306 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19878
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD BEEN EMPTY FOR A WHILE AND THAT THERE WERE NO DEVICE ISSUES, BUT THE PATIENT WAS NON-COMPLIANT. THE HEALTH CARE PROVIDER (HCP) DID NOT WANT THE PUMP TO BE REFILLED; THEREFORE, AN AUTHORIZATION FORM WAS REQUESTED IN ORDER TO TURN THE PUMP OFF. NO PATIENT SYMPTOMS WERE REPORTED. THE PUMP PREVIOUSLY DELIVERED HYDROMORPHONE, BUPIVACAINE AND BACLOFEN. FOLLOW-UP IS BEING CONDUCTED FOR ADDITIONAL INFORMATION INCLUDING THE REASON FOR THE PATIENT¿S NON-COMPLIANCE, IF ANY TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS WERE TAKEN AND THE PATIENT¿S OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662718 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR