BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5514502 · Received March 21, 2016

    Report

    Report Number
    3004209178-2016-05018
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Date of Event
    October 30, 2014
    Report Date
    March 21, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A DEVICE MANUFACTURER REPRESENTATIVE (REP) AND A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG AT AN UNKNOWN DOSE AND CONCENTRATION FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PUMP LOGS SHOWED MULTIPLE MOTOR STALLS WITH RECOVERIES. THE STALLS OCCURRED ON (B)(6) 2014 AT 14:20 WITH A RECOVERY ON (B)(6) 2014 AT 15:43; (B)(6) 2014 AT 15:35 WITH A RECOVERY ON (B)(6) 2014 AT 16:00; AND (B)(6) 2015 AT 8:50 WITH A RECOVERY ON (B)(6) 2015 AT 10:09. THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THERE WAS NO PUMP EVENT AND THE PATIENT HAD AN INFECTION NOT RELATED TO THE PUMP. THE HCP ALSO REPORTED THAT NO STALLS WERE ASSOCIATED WITH PUMP PROBLEMS. NO SYMPTOMS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169319 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR