BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3981021 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13964
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 16, 2014
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DYE TEST WAS DONE ON THE DATE OF THE REPORT AND IT WAS FOUND THE PUMP WAS NOT WORKING. TWO MONTHS AGO THE PATIENT HAD AN MRI DOE FOR A MIGRAINE AND FORM THAT DAY ON THE PUMP HAD BEEN ¿MESSED UP.¿ THE PUMP WAS CHECKED A WEEK LATER AFTER THE MRI AND IT SHOWED THAT THE PUMP HAD STALLED BUT RESTARTED ON ITS OWN. THE PATIENT FELT ¿WEIRD¿ BECAUSE HER BACK WAS HURTING AND SINCE SHE HAD THE PUMP SHE DIDN¿T¿ HAVE BACK PAIN. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) TOLD HER THEY HAD TO TURN IT UP AND THE PATIENT WAS GETTING USED TO IT. THE PUMP WAS ON THE LOWEST DOSE AND THE PATIENT DIDN¿T WANT TO INCREASE IT UNLESS NECESSARY. A FEW WEEKS AGO THE DOSE WAS BUMPED UP BECAUSE OF BACK PAIN. THERE WAS A CHANGE IN THERAPY EFFECT. THE PATIENT HAD A RECURRING URINARY TRACT INFECTION THAT SHE DID NOT KNOW ABOUT SINCE SHE WAS NOT FEELING PAIN. THE PATIENT SHOULD HAVE BEEN FEELING PAIN BECAUSE, PER THE HCP, IT WAS A TERRIBLE URINARY TRACT INFECTION. IT WAS THOUGHT THE PUMP MAY HAVE HAD A LEAK BECAUSE THE PATIENT WAS FEELING PAIN WHERE SHE SHOULD NOT HAVE BEEN. THE PATIENT WENT TO A HEALTH CARE PROVIDER A WEEK AGO FRIDAY BECAUSE HER BACK WAS STILL HURTING AND THE HCP BUMPED THE PUMP UP SOME MORE TO 21% AND THE PUMP SHOULD NOT HAVE ANYTHING TO DO WITH THE URINARY TRACT INFECTION. THE PATIENT DID NOT FEEL A DIFFERENCE AND WAS STILL IN PAIN. THE PATIENT CALLED THE HCP AGAIN SAYING SHE HAD BEEN RUNNING A FEVER BETWEEN 98 AND 102 FOR OVER A MONTH WITH TWO SETS OF ANTIBIOTICS. NOTHING WAS HELPING. THE HCP RECOMMENDED HAVING THE PUMP CHECKED TO RULE OUT INFECTION AND THE PUMP. A DYE STUDY WAS DONE ON THE DATE OF THE REPORT. THE HCP LOOKED AT THE TESTING AND RECOMMENDED THE PATIENT SPEAK TO A SURGEON TO HAVE THE PUMP REMOVED. IT WAS NOTED THE PATIENT WAS CRYING AND VERY UPSET ABOUT THE COST AND HAVING TWO ¿BIG UGLY SCARS.¿ THE PATIENT¿S HCP WANTED TO GET THIS DONE AS SOON AS POSSIBLE BECAUSE IT WAS THOUGHT IT MIGHT BE INFECTED IN THERE SOMEWHERE. THE SYSTEM WAS BEING USED TO DELIVER DILAUDID (HYDROMORPHONE).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS GOING TO BE EXPLANTED IN (B)(6) 2014, AS THE PUMP HAD MALFUNCTIONED. ADDITIONAL INFORMATION, INCLUDING DETAILS OF THIS MALFUNCTION, INTERVENTIONS AND DIAGNOSTICS/TROUBLESHOOTING PERFORMED, WAS NOT REPORTED. ADDITIONAL FOLLOW-UP TO OBTAIN THIS INFORMATION IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456867 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention