BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7586730 · Received June 11, 2018

    Report

    Report Number
    3004209178-2018-13063
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    May 16, 2018
    Report Date
    June 11, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    UDI-DI
    00613994779229
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE 10 MG/ML AT 1 0.6 MG/DAY AND FENTANYL 3000 MCG/ML AT 1598 MCG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED A MOTOR STALL OCCURRED. PER THE PRINT REPORT A MOTOR STALL OCCURRED ON (B)(6) 2018 AT 20:20 AND A RECOVERY OCCURRED ON (B)(6) 2018 AT 19:47, A MOTOR STALL OCCURRED (B)(6) 2018 AT 22:37 WITH A STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2018 AT 22:27 AND A RECOVERY OCCURRED ON (B)(6) 2018 AT 16:58, A MOTOR STALL OCCURRED (B)(6) 2018 AT 09:54 AND A RECOVERY OCCURRED ON (B)(6) 2018 AT 2:17, MOTOR STALL OCCURRED ON (B)(6) 2018 AT 08:53 AND A RECOVERY OCCURRED ON (B)(6) 2018 AT 00:22, A MOTOR STALL OCCURRED ON (B)(6) 2018 AT 01:22 WITH A RECOVERY ON (B)(6) 2018 AT 22:37, A MOTOR STALL OCCURRED ON (B)(6) 2018 AT 14:37 AND A RECOVERY OCCURRED ON (B)(6) 2018 AT 17:18, A MOTOR STALL OCCURRED ON (B)(6) 2018 AT 21:06 WITH A RECOVERY ON (B)(6) 2018 AT 19:01, A MOTOR STALL OCCURRED ON (B)(6) 2018 AT 20:52 WITH A RECOVERY ON (B)(6) 2018 AT 17:08, MOTOR STALL OCCURRED ON (B)(6) 2018 AT 03:30 WITH A STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2018 AT 03:30 WITH A MOTOR STALL RECOVERY ON (B)(6) 2018 AT 14:04, A MOTOR STALL OCCURRED ON (B)(6) 2018 AT 16:41 WITH A RECOVERY ON (B)(6) 2018 AT 13:44 AND A MOTOR STALL ON (B)(6) 2018. THE PATIENT EXPERIENCED FLU LIKE SYMPTOMS. THERE WERE NO KNOW ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP WAS REPLACED ON (B)(6) 2018. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431370 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20 00613994779229

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention