BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4255179 · Received November 17, 2014

    Report

    Report Number
    3004209178-2014-21675
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N232986, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAST YEAR THE PATIENT WAS SO BUSY THEY MISSED THEIR REFILL. THE PATIENT TOLD THEIR SPOUSE ABOUT HEARING A SOUND AND REALIZED THE PATIENT WAS REFERRING TO THE PUMP ALARM. THEY MISSED THE REFILL BY 3 MONTHS. THE PUMP WAS USED TO DELIVER BACLOFEN AND DILAUDID. NO PATIENT SYMPTOMS, INTERVENTIONS OR OUTCOME REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT THE ALARM HAD BEEN DUE TO THE PUMP BEING EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742899 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR