BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3233756 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11966
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT PATIENT HAD NOT BEEN GETTING ALONG WITH HIS DOCTOR SINCE PUMP IMPLANT REGARDING PAIN THERAPY COVERAGE. THE DOCTOR WAS NOT WILLING TO USE THE PUMP TO TREAT ¿THE OTHER 2 AREAS OF PAIN OUT OF THE 3 THAT PATIENT NEEDED TREATED¿; PATIENT WAS THEREFORE HAVING THE PUMP DEVICE REMOVED. PER REPORTER, THE DOCTOR TOOK AWAY ALL OF ORAL MEDICATIONS SO THE PAST 10 MONTHS PATIENT HAD SPENT IN PAIN. IT WAS STATED THAT PATIENT HAD NO COMPLAINTS ABOUT THE PAIN PUMP DEVICE AND THAT THE DEVICE WORKED FOR WHAT IT WAS USED FOR. THE PUMP WAS BEING REMOVED ON (B)(6) 2013. THERE WAS NO FURTHER INFORMATION PROVIDED IN REGARDS TO THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE HIS IMPLANT IN (B)(6) 2012, PATIENT HAD BEEN COMPLAINING. IT WAS STATED THAT PATIENT HAD HAD "A DOZEN BACK SURGERIES FOR WHICH HE GOT THE PUMP AND IT HADN'T WORKED RIGHT SINCE." IT WAS ADDED THAT ABOUT TWO-THREE WEEKS AGO SINCE THE DATE OF THIS REPORT, X-RAYS WERE TAKEN AND PER REPORTER ONE CAN SEE THE CATHETER COMING OUT OF THE PUMP OVER TO THE SPINE. PATIENT COULD FEEL IT STICKING OUT, "MAKING A BUMP IN THE SKIN" AND WAS NOT HAPPY. IT WAS STATED THAT THIS HAD BEEN HAPPENING SINCE MONTHS AND PATIENT HAD KEPT GOING BACK TO THE DOCTOR NOT KNOWING THAT IT WAS THE CATHETER. HE KEPT COMPLAINING THAT THIS WASN'T WORKING, AND THAT HE WAS STILL IN PAIN AND IT WAS GETTING WORSE AND WORSE, NOT GETTING BETTER. PER REPORTER THE DOCTOR REFUSED TO DO ANYTHING, HE LOOKED AT THE X-RAYS AND INDICATED THAT "IT'S OKAY;" HE MADE IT CLEAR HE DOESN'T WANT TO TALK ABOUT IT, EVERYTHING IS OKAY. PATIENT HAD SOME EXPERIENCE IN READING X-RAYS AND HAD PERSONALLY READ THE X-RAYS AS HE HAD GOT A COPY OF THEM FROM THE LAB. PATIENT WAS NOT GETTING ALONG WITH HIS DOCTOR. IT WAS INDICATED THAT AT FIRST THEY THOUGHT IT'S THE DOSE AS PATIENT WAS NOT GETTING ANY PAIN RELIEF BUT THE DOCTOR HAD INDICATED THAT THE PATIENT WAS AT THE MAXIMUM DOSE. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE AT A CONCENTRATION OF 10.0 MG/ML. PATIENT WAS SEEKING ANOTHER HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336302 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR