BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3240457 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12084
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED IT WAS UNKNOWN THE CAUSE OF THE EVENT BUT SUSPECTED MRI SCANNER/MAGNET INTERACTION WITH PUMP. THE MRI RESULTS DONE ON (B)(6) 2013 WERE UNREMARKABLE. THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FELT PAIN AT THE SCAR ACROSS THE TOP OF THE PUMP ON THE LEFT SIDE; THE PUMP POCKET SITE. THE PATIENT STATED THAT THIS ALL HAPPENED DURING THE MRI WHICH THEY WERE ABLE TO DO THE TOP AREA OF HER BODY. IT STARTED 15 MINUTES INTO THE MRI WHERE IT FELT AS A SHOCKING AND IT WAS LIKE TOUCHING AN ELECTRIC FENCE. PER THE PATIENT "IT FELT LIKE A HEATING PAD ON MY BACK THAT WAS GETTING WARMER." THE PATIENT STILL HAD AGGRAVATING PAIN AT THE PUMP LOCATION. PER THE PATIENT IT WAS NOT AN EXCRUCIATING PAIN; HOWEVER, NOT ENOUGH WHERE SHE IS IN TEARS. THE DAY BEFORE THE REPORT THE PATIENT, ABOUT 3 O'CLOCK IN THE MORNING, HAD A PAIN IN HER SIDE WHERE THE "TUBING RUNS" AROUND HER WAIST UP INTO HER SPINE. IT WOKE HER UP OUT OF A DEAD SLEEP. AND IT HAD BEEN HURTING HER ALL DAY. THE PATIENT ALSO REPORTED THEY HAD A LITTLE RASH IN HER SKIN. THE PATIENT NEVER HAD A PROBLEM WITH THE PUMP UNTIL THE MRI. THE PATIENT HAD CONTACTED THE HCP AND WAS WAITING FOR A CALL BACK ON THE RESULTS OF THE MRI WHICH WAS DONE ON TUESDAY. THE PATIENT PLANNED TO HAVE THE PUMP CHECKED. THE PUMP WAS USED TO DELIVER DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PUMP WAS CHECKED AND VERIFIED IT HAD RESTARTED AFTER THE MRI. THE PATIENT HAD AN APPOINTMENT THE FOLLOWING MONDAY AT THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340360 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR