BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2851278 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10934
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 3, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL/SERIAL #: UNK; IMPLANTED/EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS IN A COMA DAYS AFTER THE DRAINING. HE WAS REPORTED TO HAVE BEEN DOING WELL AND WAS BACK HOME. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    PLEASE REFER TO MANUFACTURER'S REPORT 3007566237-2012-02888 FOR COMA FOLLOWING SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A PUMP REPLACEMENT, FOLLOWING WHICH THE NEW PUMP WAS FILLED WITH LIORESAL 2000 MCG/ML WITH A DOSE OF 574 MCG/DAY. THE PHYSICIAN HAD NOT ASPIRATED THE CATHETER, SO THE NEW PUMP WAS PROGRAMMED WITH A BOLUS OF 0.3CC TO PRIME THE PUMP TUBING BEFORE IMPLANTING THE PUMP. THE PATIENT WAS "WELL", AND RETURNED HOME. THE PATIENT WAS FOLLOWED FOR BLEEDING AT THE POCKET SITE. ON (B)(6) 2012, THE NEUROSURGEON REVISED THE POCKET AND DRAINED THE HEMATOMA. THE PATIENT NEVER RECOVERED WELL AFTER SURGERY, AND WAS HOSPITALIZED AND INTUBATED AT THE INTENSIVE CARE UNIT. ON (B)(6) 2012, THE MANAGING PHYSICIAN SUSPECTED THAT THE SURGEON MIGHT HAVE DAMAGED THE CATHETER WHILE REVISING THE POCKET. THE PUMP WAS INTERROGATED AND A FLOW RATE PERCENT OF ERROR OF 14% (WITHIN SPECIFICATIONS) WAS NOTED. THE CATHETER ACCESS PORT WAS ASPIRATED EASILY AND A CATHETER CONTRAST STUDY REVEALED AN INTACT CATHETER. THE PUMP AND CATHETER HAD BEEN VERIFIED AND ALL ARE WORKING WELL. THE DAILY DOSE WAS INCREASED BY 15% BY THE MANAGING PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R