BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3011450 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03935
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 19, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8711, SERIAL #(B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR TO FIVE MONTHS PRIOR TO THE DATE OF THIS REPORT THE PATIENT EXPERIENCE WITHDRAWAL SYMPTOMS. THERE WAS NO ALARM HEARD, THE PATIENT HAD NOT BEEN GETTING ANY PAIN RELIEF AND IT WAS "BELIEVED THE PUMP HAD NOT BEEN WORKING." THE DOCTOR TURNED OFF THE PUMP INSTEAD OF REFILLING THE PUMP ON THE LAST REFILL APPOINTMENT AND PLANS TO REPLACE THE PUMP ON (B)(6) 2013. THE PATIENT HAD BEEN BENT OVER IN PAIN, HAVE SPASMS IN HER ABDOMINAL MUSCLES, AND HAVE PAIN THAT "INCREASED SLOWLY" FOLLOWING THE PUMP BEING TURNED OFF ON (B)(6) 2013. ON AN UNKNOWN DATE, THE PATIENT REPORTED TO HAVE SLEPT ALL DAY, WAS IN "SO MUCH PAIN", AND WAS A "SICK PERSON." THE PUMP WAS INFUSING BACLOFEN AND MORPHINE.

    Description of Event or Problem · 1

    2015-09-21 ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER INDICATED THE PATIENT HAD A RETURN OF PAIN AND COULD NOT FEEL THE MEDICATION IN 2013. THE PATIENT BELIEVED HER PUMP WAS MALFUNCTIONING, THOUGH SHE DID NOT KNOW WHAT EXACTLY WAS WRONG WITH IT. HER PUMP WAS REPLACED (EARLY 2014, MAYBE (B)(6) DUE TO THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114261 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention