BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3932807 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12986
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    April 24, 2014
    Report Date
    September 30, 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 Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT COMMITTED SUICIDE. THE INITIAL DOCTOR STATED THEY DID NOT PUT THE CATHETER IN THE SAME SPOT AS THE TEST WHICH WAS SUCCESSFUL. THE PATIENT WENT TO A SECOND DOCTOR WHO MOVED THE CATHETER AND INCREASED THE PATIENT¿S MORPHINE ¿300 FOLD¿. STILL NO RELIEF FOR THE PATIENT. THE PATIENT WAS INCREASED AND DECREASED MULTIPLE TIMES UNTIL THE PATIENT SAID ENOUGH. WHEN THE AUTOPSY WAS DONE THE PATIENT HAD SO MUCH SCAR TISSUE AND ABRASIONS IN HIS EMPTY PELVIC AREA AND THE AUTOPSY DOCTOR SITED AN ¿UNUSUALLY LONG CATHETER¿ THE REPORTER STATED THEY DIDN¿T KNOW IF THE PRESSURE OF THE PUMP AND CATHETER IN THIS RADIATION DAMAGED AREA CAUSED THE PATIENT MORE PAIN, BUT THE PATIENT WAS NEVER ABLE TO GET RELIEF. PER THE HCP THE PATIENT WAS FILLED LAST IN (B)(6) AND WAS ON MORPHINE AT 1 MG/ML AT 1 MG/DAY AND BUPIVACAINE AT 10 MG/ML AND 10 MG/DAY. PER THE HCP THAT THE PATIENT HAD TERMINAL RECTAL CANCER AND WAS STRUGGLING TO FIND PAIN RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT HAD FOUR TO FIVE INCREASES OF MEDICATION IN HIS PUMP SINCE (B)(6) 2014 AND WAS STILL HAVING PAIN IN HIS PELVIC AREA. THE PATIENT WAS ON THE SAME AMOUNT OF OXYCONTIN, OXYCODONE AND GABAPENTIN THAN BEFORE HE GOT THE PUMP. THE HEALTHCARE PROVIDER (HCP) IS AWARE OF THIS AND THE PATIENT WAS TOLD THEY WILL HAVE TO WAIT TO DO TESTING. WHEN THE PATIENT GETS TO 500MCG/DAY (EXPECTED TO OCCUR (B)(6) 2014) THEY WILL DO SOME TESTING ON THE PUMP. THE MORPHINE DOSE WAS 100.01MCG/DAY, THE PATIENT WENT IN EVERY WEEK SINCE AND THE DOSE WAS CURRENTLY 400MCG/DAY. THE PUMP WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT WAS IN MORE PAIN AFTER THE PUMP IMPLANT THAN BEFORE. IT WAS NOTED THAT THE TRIAL PROVIDED GOOD RELIEF. IT WAS NOTED THAT THE IMPLANTING PHYSICIAN PUT THE CATHETER UP A ¿LITTLE HIGHER.¿ THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN BY THE MANAGING PHYSICIAN. THE NEW PHYSICIAN INDICATED THAT THE CATHETER WAS UP TOO HIGH AND DUE TO THE SPINAL STENOSIS THE MEDICATION WAS NOT MOVING AROUND LIKE THEY HOPED IT WOULD IN THE INTRATHECAL SPACE. IT WAS NOTED THAT THE DOCTOR ADDED BUPIVACAINE TO THE MORPHINE AND HAD INCREASED THE DOSE WITH NO RELIEF. IT WAS NOTED THAT ALL THE DIAGNOSTICS SHOWED THAT THE SYSTEM WAS FINE; THE ISSUE SEEMED TO BE WITH CATHETER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409479 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other