BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6458128 · Received April 4, 2017

    Report

    Report Number
    3004209178-2017-07022
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 4, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 (HCP) VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE 5 MG/ML AT 2.2485 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PUMP WAS INTERROGATED. LOGS SHOWED: MOTOR STALL ON (B)(6) 2017 AT 1703 RECOVERY ON (B)(6) 2017 AT 1858 MOTOR STALL ON (B)(6) 2017 AT 1708 RECOVERY ON (B)(6) 20107 AT 1313 MOTOR STALL ON (B)(6) 2017 AT 1741 RECOVERY ON (B)(6) 2017 AT 2032 MOTORSTALL ON (B)(6) 2017 AT 2246 RECOVERY ON (B)(6) 2017 AT 0051 MOTOR STALL ON (B)(6) 2017 AT 0414 RECOVERY ON (B)(6) 2017 AT 0239 MOTOR STALL ON (B)(6) 2017 AT 0413 RECOVERY ON (B)(6) 2017 AT 1223 MOTOR STALL ON (B)(6) 2017 AT 1331 STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2017 AT 1331. THE PATIENT DENIED HAVING BEEN EXPOSED TO ANY MAGNETS OR ANY ENVIRONMENTAL/DIAGNOSTIC FACTORS THAT COULD CONTRIBUTE TO MOTOR STALL. WHEN THE PATIENT TRIED TO GIVE HERSELF A BOLUS WITH THE PERSONAL THERAPY MANAGER (PTM), THE PTM DISPLAYED A MESSAGE - ALTHOUGH THE PATIENT DID NOT SPECIFY MESSAGE SHE SAW. THE PATIENT WAS NOT HEARING THE CRITICAL ALARM, WHICH WAS SET FOR EVERY ONE HOUR. A NEUROSURGEON WAS CONTACTED BY THE MANAGING HCP. IF THE NEUROSURGEON COULD NOT ACCOMMODATE THE PUMP REPLACEMENT IN A TIMELY MANNER, THE MANAGING HCP WOULD REACH OUT TO ANOTHER HCP. SURGICAL INTERVENTION WAS PLANNED, BUT IT HAD NOT YET OCCURRED OR BEEN SCHEDULED. ALTHOUGH THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT, THE PATIENT¿S STATUS WAS ALIVE ¿ NO INJURY. THE PATIENT¿S OTHER KNOWN MEDICATIONS INCLUDED OXYCONTIN, OXYCODONE, AND LYRICA. THE PATIENT¿S MEDICAL HISTORY INCLUDED STATUS POST LAMINECTOMY SYNDROME, SPONDYLOSIS, HYPERTENSION, ULCER, ANEMIA, AND GASTROESOPHAGEAL REFLUX DISEASE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239856 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention