BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3071456 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06639
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT SOME POINT THIS PATIENT HAD "PLAIN FILMS" DONE, HOWEVER, A DYE STUDY WAS TO BE DONE ON THE DATE OF THE REPORT TO VERIFY CONNECTION AND CATHETER INTEGRITY AS THE PATIENT REPORTEDLY HAD THERAPY ISSUES AFTER A PUMP REPLACEMENT ON (B)(6) 2013. THE PHYSICIAN'S DICTATION NOTED SHE DID ASPIRATE FROM THE CATHETER ACCESS PORT (CAP) AFTER PIGTAIL THAT WAS CONNECTED TO THE CATHETER AND WAS ALSO CONNECTED TO THE PUMP. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2013. THE HEALTH CARE PROVIDERS HAD BEEN ASSISTING THE PATIENT SINCE THEN. THE PATIENT RECEIVED A BOLUS AND REPORTEDLY DID NOT REALLY RESPOND. IN ADDITION, THE PUMP SETTINGS ALSO "WENT UP" WITHOUT MUCH RESPONSE FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE HIGHLY ANXIOUS. THIS DEVICE SYSTEM WAS THOUGHT TO HAVE DELIVERED GABLOFEN. 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
    171401 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1