BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3813435 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09045
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NON-CRITICAL ALARM WAS HEARD FOR LOW PUMP RESERVOIR. THE DOCTOR REPORTEDLY INTERROGATED THE PUMP, AND THE PROGRAMMER SHOWED THAT THE PUMP WAS EMPTY. IT WAS NOTED THAT THE PATIENT WAS NOT EXPERIENCING ANY WITHDRAWAL SYMPTOMS. IT WAS BELIEVED THAT THE PUMP WAS NOT UPDATED TWO WEEKS PRIOR TO REPORT WHEN IT WAS REFILLED. IT WAS NOTED THAT THE DOCTOR PLANNED TO DO A SIDE PORT ASPIRATION ON (B)(6) 2014 TO DETERMINE IF THE PUMP WAS FULL. IT WAS NOTED THAT THE ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT. REPORTEDLY THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE NO INJURY¿. IT WAS NOTED THAT THE PUMP WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED THAT THIS DOCTOR WAS A NEW DOCTOR FOR THE PATIENT, AND THE PATIENT'S FILE FROM THE OTHER HEALTH CARE PROFESSIONAL (HCP) STATED THAT THE PUMP HAD BEEN REFILLED TWO WEEKS PRIOR TO REPORT. IT WAS DETERMINED THAT THE PUMP WAS NOT UPDATED TWO WEEKS PRIOR TO REPORT AS THE LAST UPDATE WAS (B)(6) 2013. IT WAS FURTHER REPORTED THAT THE DOCTOR WAS ABLE TO ASPIRATE 30 ML OF THE DRUG FROM THE PUMP. THE PUMP RESERVOIR VOLUME WAS REPORTEDLY UPDATED AND THE PATIENT WAS DOING WELL. IT WAS ADDITIONALLY REPORTED THAT "IT WAS APPARENT THAT THE PUMP WAS NOT UPDATED DURING THE (B)(6) REFILL." IT WAS NOTED THAT THE ASPIRATED 30ML OF BACLOFEN WAS CONSISTENT WITH THE DAILY DOSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OTHER PHYSICIAN HAD MADE A PROGRAMMING ERROR. IT WAS DIAGNOSED DURING THE REFILL AND RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290626 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR