BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4101552 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17354
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# N177541020, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL BECAUSE SHE WAS NON-COMPLIANT. THE LOW RESERVOIR ALARM WAS SET TO OCCUR ON (B)(6) 2014 AT A 2ML RESERVOIR VOLUME. AT THE TIME OF THIS REPORT, AN ALARM WAS OCCURRING, BUT TELEMETRY HAD NOT YET BEEN PERFORMED. IT WAS CALCULATED THAT THE PUMP WOULD BECOME EMPTY ON (B)(6) 2014. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN AND MORPHINE. THE PATIENT¿S MEDICAL STATUS PRIOR TO THE REPORT, ALARM DETAILS, PATIENT SYMPTOMS, TREATMENT/INTERVENTIONS, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585000 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR