BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3971062 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13760
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPLACEMENT OF THIS DEVICE FOR NORMAL BATTERY DEPLETION, A BLACK, HARD PIECE OF MATERIAL WAS FOUND AROUND THE CONNECTOR BETWEEN THE PUMP AND THE CATHETER. IT WAS REPORTED THAT THE PUMP CONNECTOR WAS CHANGED AS THERE WAS NO LIQUOR BACKFLOW. NO ACTION WAS REQUIRED. THE ISSUE WAS NOT RESOLVED AND THE CAUSE WAS NOT DETERMINED. THERE WERE NO PATIENT SYMPTOMS REPORTED WITH THIS EVENT. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED MORPHINE. ADDITIONAL INFORMATION WAS REQUESTED. IT WAS FURTHER REPORTED THAT THE CONNECTOR SEGMENT WAS DISCARDED AS THE PATIENT AND PHYSICIAN REFUSED THE RETURNING OF THE PRODUCT. IT WAS UNKNOWN IF THE CUSTOMER DID PERFORM ANALYSIS ON THE HARD, BLACK MATERIAL. IT WAS UNKNOWN HOW THE CATHETER PERFORMED UNTIL THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448334 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR