BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3072684 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06735
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J90070744, IMPLANTED: (B)(6) 1990. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FELT LIKE SHE WAS EXPERIENCING WITHDRAWAL SYMPTOMS. HER SPECIFIC SYMPTOMS INCLUDED: INCREASED PAIN IN THE BACK AND LEGS, FEELING SICK, AN UPSET STOMACH, AND A "HOLLOW-OUT" IN HER EARS WHICH MADE IT SOUND LIKE SHE WAS TALKING THROUGH HER EARS OR HEAD. SHE WOULD ALSO EXPERIENCE A "JERKING" IN HER BODY WHICH COULD CAUSE HER TO DROP THINGS. IT WAS STATED THAT THESE SYMPTOMS HAD STARTED OCCURRING SINCE A NEW PUMP WAS PUT IN ABOUT SIX MONTHS PRIOR TO REPORT. THE PATIENT HAD BEEN UNABLE TO CONTACT HER MANAGING PHYSICIAN. SHE HAD BEEN GIVEN ORAL PERCOCET AND PHENERGAN TO HELP MANAGE ANY SYMPTOMS. THE PATIENT ALSO HAD BEEN TO THE HOSPITAL EMERGENCY ROOM (ER) FIVE TIMES SINCE HER PUMP WAS REPLACED. IT WAS ORIGINALLY THOUGHT THAT THE PATIENT WAS EXPERIENCING "DIGESTIVE ISSUES", BUT TESTS WERE RUN AND NOTHING WAS FOUND. THE PATIENT WAS GIVEN PAIN SHOTS AND SENT HOME. SHE WOULD BE "GOOD FOR MAYBE A WEEK" AFTER VISIT TO THE E.R. THE PAIN CENTER AT THE HOSPITAL NARROWED DOWN THE ISSUES TO THE PUMP. THE DEVICE SYSTEM WAS INFUSING MORPHINE AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE HOSPITAL¿S PAIN CENTER STATED THAT THE PUMP WAS ¿BAD¿. IT WAS ALSO STATED THAT THERE WAS ¿A MYELOGRAM TO PROVE IT WAS GOOD¿. IT WAS NOTED THAT THE PATIENT STILL HAD THE ORIGINAL TUBING IN. THE PATIENT HAD RECEIVED ASSISTANCE FROM HER DOCTOR OR MEDTRONIC REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. AN APPOINTMENT WAS NOTED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174318 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1