BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4214094 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20665
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL# HG07EA408, IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DYE STUDY WAS PERFORMED AND THAT ¿LOOKED FINE.¿ IT WAS UNKNOWN WHY THERE WERE DOING A DYE STUDY. IT WAS FURTHER REPORTED DRUG SQUIRTED OUT OF THE NEEDLE; HOWEVER WHEN THEY INSERTED THE NEEDLE THE SYRINGE WAS NOT ATTACHED. IT WAS ALSO REPORTED THEY WERE EXPECTING ABOUT 30CCS AND GOT BACK ONLY 20CCS. THE MANUFACTURER REPRESENTATIVE (REP) WAS GOING TO MAKE SURE THEY GOT THE ENTIRE DRUG OUT OF THE PUMP AND THEN FILL IT AGAIN AND CALL BACK IF NEEDED. IT WAS FURTHER REPORTED THE HEALTHCARE PROVIDER (HCP) REMOVED DRUG FROM THE CATHETER AND THE PUMP AND HE REFILLED THE PUMP WITHOUT ISSUE. HE HAD THOUGHT MAYBE MORE DRUG HAD SQUIRTED OUT OF THE NEEDLE THAN HE ORIGINALLY THOUGHT. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PUMP WAS BEING USED TO DELIVER INTRATHECAL BACLOFEN THERAPY. IT WAS UNKNOWN IF THE PATIENT EXPERIENCED ANY SYMPTOMS REGARDING THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695877 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR