BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3932281 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12968
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4) IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TWO PUMP STALLS AND "AT SOME POINT DID RECOVER". THE PATIENT HAD WITHDRAWAL SYMPTOM AND UNDER DOSE SYMPTOMS. A REPLACEMENT WAS SCHEDULED WITH A SURGEON TOMORROW. A RECOVERY WAS NOTED TO BE MORE THAN TWO HOURS. THE MEDICATION IN THE PUMP WAS UNKNOWN. IT WAS FURTHER REPORTED THE PATIENT CANCELLED THEIR REPLACEMENT SURGERY BECAUSE THEY WERE NOT INTERESTED IN COMPLETING THE NECESSARY STEPS FOR PREOP CLEARANCE. THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO READ THE PUMP OR GET INFORMATION ABOUT THE MOTOR STALL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE UNDERDOSE SYMPTOMS INCLUDED INCREASED PAIN, NAUSEA, AND DIAPHORESIS. THE MOTOR STALLS RECOVERED AT UNKNOWN DURATIONS, BUT WERE NOTED TO HAVE OCCURRED OVER A LONG DURATION. THE CAUSE FOR THE STALLS WAS UNKNOWN. A DYE STUDY AND DOSE ADJUSTMENTS HAD BEEN PERFORMED. THE PATIENT HAD A NEW PUMP REPLACEMENT, AND REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PATIENT'S PUMP WAS INTENDED TO INFUSE FENTANYL, DILAUDID, AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410939 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention