BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2991592 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03405
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 6, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PROGRAMMER MODEL: 8835, SERIAL# (B)(4). CATHETER: MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: UNKNOWN. CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNKNOWN. CATHETER: MODEL: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FLYING AND AS SOON AS THEY TOOK OFF THE PUMP "STARTED PUMPING SO FAST NON-STOP" AND DUE TO THE BUPIVACAIN IN HIS PUMP HE WAS UNABLE TO AMBULATE AND GETTING OFF THE PLANE REQUIRED A WHEELCHAIR. THE PATIENT KNEW HE WAS GETTING TOO MUCH MEDICINE BECAUSE ONE OF THEM MAKES HIM ITCH. IT WAS ALSO REPORTED THAT THE PATIENT "FEELS NOTHING" FROM DRUG BOLUSES. IT WAS REPORTED THAT THE PATIENT HAVING A BAD REACTION TO PRIALT IN THE PUMP. IT WAS REPORTED THAT THERE ARE ONGOING PROBLEMS WITH THE PUMP THERAPY AND RECENTLY "THINGS HAVE TAKEN A TURN FOR THE WORST." VOLUME DISCREPANCIES WERE REPORTED BUT THEY WERE WITHIN SPECIFICATIONS. THE PUMP WAS INFUSING FENTANYL, BUPIVACAINE, AND PRIALT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD WITHDRAWAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD 30% OF ITS DRUG LEFTOVER AT REFILL APPOINTMENTS. THE PATIENT HAD A 40 ML PUMP AND THERE WERE 12 ML LEFT AT A RECENT REFILL. THE PATIENT HAD BEEN TOLD THERE WAS SOMETHING "VERY, VERY WRONG WITH" HIS PUMP. THE PATIENT HAD AN UPCOMING APPOINTMENT WITH THEIR DOCTOR.

    Description of Event or Problem · 1

    ALL INFORMATION REGARDING WITH THIS EVENT WILL NOW BE REPORTED UNDER THIS MANUFACTURER REPORT #. PLEASE SEE MANUFACTURER REPORT # 3004209178-2013-04761 AND MANUFACTURER REPORT # 3004209178-2014-08520 FOR PREVIOUSLY REPORTED INFORMATION. IT WAS LATER REPORTED THAT THE PUMP WAS BROKEN. THERE WAS NO QUESTION THAT IT WAS BROKEN. THE PATIENT HAD A MAXIMUM OF 400 BOLUS ACTIVATIONS BETWEEN REFILLS. THE PATIENT USED ALL OF THEM AND THERE WAS STILL 12 TO 13ML LEFT OVER IN THE PUMP EACH TIME HE WENT IN FOR A REFILL. THIS BEGAN 2 YEARS PRIOR TO THIS REPORT. IN ADDITION, THE PATIENT FELT NO RELIEF FROM THE BOLUSES. THE ACTIVATIONS WERE SUCCESSFUL, BUT HAD NOT EFFECT AT ALL. IT WAS NOTED THAT THE PATIENT GOT A NEW PERSONAL THERAPY MANAGER (PTM) ABOUT A MONTH PRIOR TO THIS REPORT BECAUSE HE THOUGHT THAT WAS THE ISSUE, BUT IT MADE NO DIFFERENCE. THE PATIENT'S MOST RECENT ALARM DATE WAS (B)(6) 2014, BUT HIS PTM STATED THAT IT WAS (B)(6) 2014. THIS WAS ANOTHER ISSUE. THE REPORTER WAS POSITIVE THAT THE SYSTEM WAS INACCURATE AND "UNSYSTEMICALLY" DELIVERING MEDICATION. THE PATIENT STARTED HAVING ALL OF THESE ISSUES 2 YEARS PRIOR TO THIS REPORT AND A SIDE PORT STUDY OF THE PUMP WAS DONE. THE PATIENT SAW 2 OTHER DOCTORS FOR A SECOND AND THIRD OPINION. THEY BOTH AGREED THAT THE PUMP WAS NOT INFUSING CORRECTLY. HOWEVER, THESE DOCTORS WOULD NOT SEE THE PATIENT BECAUSE NO ONE WANTED TO TOUCH THE PUMP. THE BUPIVACAINE WAS NOT INFUSING CORRECTLY IN THE PUMP AND THIS WAS SUSPECTED TO BE THE CAUSE OF THE PATIENT'S KIDNEY FAILURE. THE PATIENT'S UROLOGIST SAID THAT HE WAS TOO OLD FOR A TRANSPLANT AND WAS NOT A GOOD CANDIDATE, SO HE TOLD HIM THAT HE WOULD DIE IN 6 TO 12 MONTHS. THIS STARTED 2 YEARS PRIOR TO THIS REPORT, AT THE SAME TIME AS THE VOLUME DISCREPANCIES. THE VOLUME DISCREPANCIES WERE CAUSING ITCHING TO THE PATIENT'S LEFT HIP. HE WAS TOLD BY 3 DERMATOLOGISTS THAT THIS WAS AN ALLERGIC REACTION. HE HAD USED PILLS, CREAMS AND HYDROXYZINE TO CONTROL IT. THE PATIENT WAS TOLD THAT HE WOULD "NOT LIVE TO SEE (B)(6)". THE PATIENT JUST BOUGHT THE "CALMARE UNIT", WHICH WAS LIKE A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT THAT WAS USED 10 TIMES PER DAY. IF THAT WORKED, THE PATIENT WOULD BE WEANED DOWN AND HAVE THE PUMP REMOVED. THE PATIENT WANTED TO BE WEANED AND HAVE THE PUMP REMOVED. PER MANUFACTURER REPRESENTATIVES, "EVERYTHING IS NORMAL", DESPITE THE "OBVIOUS" DISCREPANCIES AND LACK OF EFFICACY. THE PATIENT TRIED TO SEE 10 DIFFERENT DOCTORS AND NO ONE WOULD SEE HIM BECAUSE HE HAD A "BUSTED PUMP". THE PATIENT DID NOT FEEL DIFFERENCES BEFORE OR AFTER REFILLS. IN THE MONTH PRIOR TO THIS REPORT, THE PATIENT HAD A REFILL THAT WAS "POTENTIALLY FOLLOWED BY WITHDRAWAL SYMPTOMS", BUT IT WAS HARD TO TELL WITH ALL OF THE OTHER SYMPTOMS THAT WERE OCCURRING SINCE THE COMA. IT WAS NOTED THAT A SIDE PORT STUDY OF THE PUMP WAS DONE. AT THE TIME OF THIS REPORT, THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE, FENTANYL AND MORPHINE. IT WAS LATER REPORTED THAT PATIENT SAW A DOCTOR FOR A PAIN STIMULATION TRIAL ON (B)(6) 2014 AND THEY HAD TO "ABORT" IN THE MIDDLE OF THE PROCEDURE BECAUSE THE PUMP CATHETER WAS IN THE WAY. THE PATIENT ASKED IF THE CATHETER WAS NICKED OR DAMAGED IN ANYWAY AND THEY SAID NO. THE PATIENT SUSPECTED THAT SOMETHING MAY HAVE HAPPENED BECAUSE HIS URINARY RETENTION ISSUES AND SEVERE LOCALIZED ITCHING ON HIS HIP WENT AWAY AND HIS BOLUSES WERE HAVING NO EFFECT. BOTH SYMPTOMS HAD RETURNED "WITH A VENGEANCE" AND HE STILL HAD NO EFFECT FROM THE BOLUS DOSES. TWO DAYS LATER, THE PATIENT SAW A UROLOGIST, WHO SAID THAT IF THEY DO NOT GET HIS URINARY RETENTION ISSUES UNDER CONTROL, HIS BLADDER WOULD CEASE TO FUNCTION ENTIRELY. AFTER THAT APPOINTMENT, THE PATIENT WENT TO SEE HIS PRIMARY CARE PROVIDER (PCP) FOR SOME BLOOD TEST RESULTS, WHICH WERE NOT DEVICE RELATED. PLEASE SEE MANUFACTURER REPORT # 3004209178-2013-07366 FOR INFORMATION REGARDING THE REPORTED COMA.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN HAVING SEVERE ITCHING FOR 2 YEARS AND HAD SEEN 3-4 DERMATOLOGISTS. A BIOPSY WAS DONE. THEY STATED THAT IT WAS DUE TO ONE OF MEDICATIONS IN THE PUMP AND THE AREA IT WAS PUMPING TO WAS SENSITIVE TO THE MEDICATION. THE PATIENT¿S HCP AND SHE GAVE HIM SOME HYDROXYZINE AND PILLS TO STOP THE ITCHING, BUT NOTHING WORKED. THE PATIENT BOUGHT CREAMS AND SPRAYS AND IT DIDN¿T HELP. IT WAS NOTED THAT THIS WAS A MINOR ISSUE AND THE PATIENT¿S MAIN CONCERN WAS URINARY RETENTION AND THE BUPIVACAINE DOSING HIS URINARY AREA AND MAKING IT NUMB AND CAUSING HIM NOT TO GO TO THE BATHROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94794 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1