BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2884191 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12193
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 26, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT THROUGH WITHDRAWAL. IT WAS INDICATED THAT THE PATIENT HEARD HER ALARM GO OFF TWICE ON (B)(6) 2012. THE FIRST BEING AT 02:30 A.M. AND AGAIN AT 03:30 A.M. AND THIS WAS WHEN THE SYMPTOMS BEGAN. THE PATIENT'S BOWEL HAD RELEASED REALLY BAD AND HER HEART WAS POUNDING. THE PATIENT WENT TO THE HOSPITAL AND WAS GIVEN ORAL MEDICATION (DILAUDID) TO GET HER THROUGH UNTIL HER PUMP WAS CHECKED. IT WAS NOTED THE NIGHT OF (B)(6) 2012 THAT THE PATIENT WAS SICK BECAUSE SHE HADN'T EATEN IN 3 DAYS. IT WAS REPORTED THAT SHE HAD "NAUSEA AND EVERYTHING." IT WAS STATED THAT IT WAS THE WORST NIGHT OF HER LIFE AND SHE THOUGHT SHE WAS GOING TO DIE. IT WAS NOTED ON THE MORNING OF (B)(6) 2012 THAT SHE WAS FEELING BETTER BUT SHE WAS SHAKING AND HER WHOLE BODY WAS TREMBLING. IT WAS ALSO NOTED THAT THE END OF LIFE (EOL) OF THE PUMP WAS (B)(6) 2013. THE PATIENT HAD AN APPOINTMENT SCHEDULED ON (B)(6) 2012 TO SEE HER PHYSICIAN. THE PATIENT OUTCOME WAS NOT PROVIDED. THE DRUGS DELIVERED VIA PUMP WERE BUPIVACAINE AND DILAUDID. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS THOUGHT TO BE KINKED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1