BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3941217 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13164
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP REFILL OCCURRED PRIOR TO (B)(6) 2014. AFTER THAT REFILL, THE PATIENT HAD SYMPTOMS; THE PATIENT WAS VERY SLEEPY ROUGHLY 1 WEEK AFTER THE REFILL OCCURRED. THE SYMPTOMS DID NOT OCCUR RIGHT AFTER THE REFILL; THEY WERE DELAYED. IT WAS UNKNOWN IF THE DRUG HAD BEEN CHANGED AT ALL AT THE VISIT. ON (B)(6) 2014, THE PATIENT CAME IN FOR A PUMP REFILL AND THE ACTUAL RESIDUAL VOLUME (0 ML) WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (5.9 ML). THE PUMP WAS REFILLED WITH SALINE. ON (B)(6) 2014 THE PATIENT CAME IN AGAIN TO CHECK THE RESERVOIR VOLUME AND THE ACTUAL RESIDUAL VOLUME (4 ML) WAS AGAIN LESS THAN THE EXPECTED VOLUME (12 ML). AS OF THE DATE OF THIS REPORT, THE PATIENT WAS ON ORAL PAIN MEDICATION AND STILL HAD SALINE IN THE PUMP. THE HCP (HEALTHCARE PROVIDER) WAS PLANNING ON KEEPING THE PATIENT ON THE ORAL DILAUDID AND SEE HOW SHE DID. PRIOR TO THE SALINE, THE DEVICE SYSTEM WAS DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419764 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1