BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3873041 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11594
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DYE STUDY PERFORMED ON (B)(6) 2014, AND THEY WERE UNABLE TO EXTRACT ANY MEDICINE OR SPINAL FLUID OUT OF THE CATHETER. THE MANUFACTURER'S REPRESENTATIVE REPORTEDLY TOLD THE PATIENT THAT THE CATHETER HAD NOT BEEN REPLACED "LAST YEAR", HOWEVER THE MANUFACTURER'S RECORDS INDICATE OTHERWISE. THE MANUFACTURER'S RECORDS INDICATE THAT THE PUMP AND CATHETER HAD BEEN REPLACED ON (B)(6) 2013. THE PUMP WAS INFUSING CLONIDINE, BUPIVACAINE, AND DILAUDID. REFER TO MANUFACTURER REPORT # 3004209178-2013-04742 PREVIOUS PUMP AND CATHETER ISSUES AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349237 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR