BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3072834 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06746
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, LOT# J10854R69, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAY AFTER THE REFILL ON (B)(6) 2013, THE PATIENT EXPERIENCED EXTREME PAIN IN HER LOWER BACK AND LEGS. THE PATIENT REPORTED DIFFICULT AND PAINFUL WALKING AND HAD DENIED ANY FALLS, TRAUMAS, CHANGES TO THE PUMP SITE, FEVER, AND WITHDRAWALS. THE PATIENT WAS CONCERNED THAT HER CATHETER COULD HAVE MOVED. THE PATIENT CONTACTED HER PUMP PHYSICIAN AND WAS WAITING A CALL BACK. THE PATIENT ALSO CONTACTED THE PHYSICIAN WHO HAD REPLACED HER HIP APPROXIMATELY THREE YEARS AGO. THIS DEVICE SYSTEM DELIVERED MORPHINE. THE PATIENT LATER REPORTED THAT THE PAIN WAS SOMEWHAT BETTER BUT THOUGHT PERHAPS SHE WAS "GETTING MESSED UP" AS THE IMPLANTING PHYSICIAN WAS NOT THE PHYSICIAN WHO REFILLED HER PUMP. THE PATIENT WAS ABLE TO SCHEDULE AN APPOINTMENT FOR (B)(6) 2013 BUT FELT THIS WAS A LONG TIME TO WAIT. SHE WAS INFORMED TO GO TO THE EMERGENCY ROOM IF NECESSARY. REPORTEDLY, THE PHYSICIAN COULD ONLY DO REFILLS AND NOT A DYE STUDY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE WAS RELATED TO ¿A DISK INJURY¿ AND WAS NOT A PUMP ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR AND HER CONCERNS WERE RESOLVED. IT WAS NOTED ¿SURGERY¿ OCCURRED 04/01/2013 THE TYPE OF SURGERY WAS NOT REPORTED, IT WAS NOT NOTED IT THE SURGERY WAS RELATED TO THE DEVICE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174235 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR