BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2842078 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10634
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PATIENT HAD EXPERIENCED WITHDRAWAL; ON (B)(6) 2012 REPORTED TO THE HEALTHCARE PROVIDER (HCP) AROUND NOON THAT HE STARTED FEELING SOME SYMPTOMS OF WITHDRAWAL AND WENT TO THE ER. THERE WERE NO PUMP ALARMS; DRUGS DELIVERED VIA THE DEVICE WERE SUFENTANIL AND BUPIVACAINE. AS OF THE DATE OF THIS REPORT IT WAS REPORTED THAT THE "IT WAS NOT ACTUALLY WITHDRAWAL. THEY HAD REPLACED PATIENT'S PUMP MEDS TO A DIFFERENT MEDICATION AND SENT HIM TO SEE A NEUROSURGEON BECAUSE THE CATHETER NEEDED TO BE REPLACED BECAUSE IT WAS OCCLUDED." HCP HAD NOT HEARD FROM THE PATIENT SINCE. PER PATIENT'S PRIOR HCP PATIENT HAD NEVER HAD ANY ISSUES AND HAD GOT TO (B)(6) IN PERFECT CONDITION. HE HAD BEEN ON A STABLE DOSE FOR YEARS, NO ORAL MEDS, AND WAS A GREAT PATIENT; "HE IS NEEDY BUT HE IS A GOOD MAN AND HE HAS A VERY SUPPORTIVE WIFE WHO LOVES HIM." HE HAD LAST SEEN THE PATIENT ON (B)(6) 2012 FOR A REFILL. IT WAS ADDED THAT THE PATIENT HAD THEN VISITED ANOTHER HCP WHEN IN (B)(6) BECAUSE HIS PENIS FELT NUMB AND THE HCP DECIDED TO SWITCH OUT THE PUMP MEDS. HE KEPT THE DOSE THE SAME BUT CHANGED THE CONCENTRATIONS. HE GAVE THE PATIENT AN MRI AND IT WAS NORMAL. PER THE HCP THE PATIENT DID NOT HAVE A RESPONSE TO THE MEDICATION SO HE TRIED TO ASPIRATE THE CAP (CATHETER ACCESS PORT) BUT WAS UNSUCCESSFUL AND NO CONTRAST WAS GIVEN. HCP DECIDED THAT IF THE PATIENT WAS NOT BETTER BY (B)(6) 2012, HE WOULD SEND HIM TO SEE THE NEUROSURGEON AND HAVE THE CATHETER REPLACED. FURTHER INFORMATION OBTAINED LATER: DURING THE (B)(6) 2012 REFILL HCP TOOK THE CLONIDINE OUT OF THE PUMP, BUT CONTINUED WITH SUFENTANIL AND BUPIVACAINE. IT WAS ADDED THAT PATIENT ARRIVED IN PHOENIX ON THURSDAY (B)(6) 2012, BUT BY (B)(6) 2012, PATIENT STARTED GETTING A WARM FEELING AND HIS PAIN STARTED TO INCREASE. FROM THAT POINT HE GOT WATERY EYES, YAWNS, SWEATING, RESTLESS, AND ACHY, AND FELT THIS WAS WITHDRAWAL. IT WAS NOTED THAT PATIENT WAS VERY UNCOMFORTABLE SINCE (B)(6) 2012 AND HAD NOT BEEN DOING TOO MUCH ACTIVITY WISE. HE HAD FEVERS, CHILLS, NIGHT SWEATS, BLURRED VISION, SHORTNESS OF BREATH, COUGH OR COUGHING UP BLOOD, BLOOD IN THE STOOL, DIARRHEA ALTERNATING WITH CONSTIPATION, JOINT PAIN, MORNING STIFFNESS, SWELLING, SKIN DISORDERS, WEAKNESS, NUMBNESS AND TINGLING, DIZZINESS, AND DEPRESSION. HE DOES COMPLAIN OF FULLNESS IN HIS INTESTINES THAT HE FEELS LIKE HE HAS TO HAVE A BOWEL MOVEMENT "ALL THE TIME." HE DOES NOT SLEEP WELL. HCP BELIEVED THAT THE ONSET OF SYMPTOMS SEEMED TO CORRELATE WITH CHANGE OF HIS MEDICATIONS ON (B)(6) 2012; HOWEVER IT APPEARED THAT HE DID HAVE OPIOID WITHDRAWAL SYMPTOMS. HE HAD THIS ONCE BEFORE WHEN HE WAS SWITCHED FROM FENTANYL TO SUFENTANIL AND THE SUFENTANIL WAS UNDER DOSED (ABOUT 3 MONTHS AGO). HE WAS DOING FINE UP UNTIL (B)(6) 2012. HE CALLED THE HOSPITAL WHERE THEY TOLD HIM THAT THE REGULAR STAFF WAS NOT ON UNTIL MONDAY AND HE WAITED UNTIL MONDAY TO GO AND BE SEEN, BUT BY THAT TIME HE LOST FEELING IN HIS PENIS AND FOUND IT VERY DIFFICULT TO URINATE. A MRI PERFORMED ON (B)(6) 2012 DID NOT SHOW CAUDA EQUINA SYNDROME. IT WAS NOTED THAT THE SYMPTOMS HE HAD WITH NUMBNESS AROUND HIS PENIS AND INABILITY TO URINATE COULD BE SECONDARY TO PATIENT RECEIVING TOO MUCH BUPIVACAINE. ATTEMPTS AT TRYING TO WITHDRAW FLUID THOUGH THE ACCESSORY PORTAL OF HIS PUMP WERE UNSUCCESSFUL, "IMPLYING THAT THE TUBING WAS EITHER NOT IN THE INTRATHECAL SPACE, AGAINST SOME TYPE OF WALL OR OCCLUSION, IS KINKED, OR IS NOT CONNECTED TO THE PUMP, CAUSING WITHDRAWAL SYMPTOMS." AFTER DISCUSSION, HCPS DECIDED TO SWITCH OUT THE FLUID IN HIS PUMP AND SEE IF THIS GAVE HIM BETTER RELIEF. THIS WAS TO BE DONE ON FRIDAY (B)(6) 2012 AND IF PATIENT DIDN'T SHOW RESPONSE BY MONDAY, (B)(6) 2012, THEN HE WOULD BE REFERRED TO A NEUROSURGEON FOR EVALUATION. IT WAS NOTED THAT PATIENT WAS TO BE RETURNING TO (B)(6) IN 2-3 WEEKS. PATIENT CONTINUED TO RECEIVE SUFENTANIL AND BUPIVACAINE. HE DID RECEIVE A BRIDGE BOLUS AND HIS NEW REFILL DATE WAS (B)(6) 2012. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention