BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2895039 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00096
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PREVIOUSLY REPORTED CORRECTION NUMBER NO LONGER APPLICABLE.

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WITH NO MOTOR STALL RECOVERY WAS REPORTED. THE STALL WAS CAUSED BY PATIENT HAVING MRI FOR BREAST CANCER. HEALTHCARE PROVIDER (HCP) CHECKED THE PUMP 15MINUTES AFTER PATIENT LEFT THE MRI MACHINE AND IT HADN'T RECOVERED. HCP THEN INTERROGATED PUMP AGAIN, AND UPDATED THE PUMP AND IT READ "RESTART DUE TO RESTART COMMAND", HCP HEARD A NOISE; HOWEVER, THE PUMP LOGS DID NOT SHOW A MOTOR STALL RECOVERY. DRUG DELIVERED VIA THE DEVICE WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THERE WAS NO MOTOR STALL WITH MRI, THE PUMP WAS CHECKED AFTER MRI AND WAS FOUND TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3113 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR