BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3071231 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06664
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8591-38, LOT# D10033, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DYE STUDY HAD BEEN PERFORMED ON (B)(6) 2013 AND THE CATHETER HAD A BLOCKAGE. IT WAS NOTED THAT THE HEALTH CARE PROVIDER (HCP) HAD TO PUT DYE IN TWICE IN ORDER TO SEE. IT WAS NOTED THERE HAD BEEN NO REFILLS SINCE (B)(6) 2012 AND THE PATIENT WAS UNSURE IF THERE WAS MEDICATION IN THE PUMP. THE PATIENT WAS NOT GETTING ANY RELIEF FROM THE PUMP AND REPORTED NOT HAVING THERAPEUTIC EFFECT SINCE APPROXIMATELY 3 TO 4 MONTHS AFTER IMPLANT. THE PATIENT HAD BEEN EXPERIENCING WITHDRAWAL SYMPTOMS SINCE (B)(6) 2013 WITH LIGHTHEADEDNESS, FEELING COLD AND HOT, SWEATING AND FEELING SICK TO HIS STOMACH. THE PATIENT CONTACTED HIS HCP AND RECEIVED CLEARANCE TO TAKE PERCOCET, AND SINCE THAT TIME HE HAD BEEN FEELING BETTER. THE PATIENT INDICATED THAT THE PERCOCET DID NOT ADDRESS THE PAIN BUT IT HELPED WITH THE WITHDRAWAL. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE HCP PULLED OUT ALL THE MEDICATION FROM THE PUMP AND THE PATIENT WAS GOING THROUGH HORRIBLE WITHDRAWAL. THE HCP REMOVED THE DRUG AND PUT IN SALINE. THE PATIENT NOTED BEING TOLD THAT THE CATHETER WAS KINKED AND NEEDED TO BE REMOVED. IT WAS LATER REPORTED THAT THE PHYSICIAN ATTEMPTED TO ASPIRATE THE CATHETER, AND WAS UNABLE TO ASPIRATE. IT WAS ALSO NOTED THAT WHEN ATTEMPTING A DYE STUDY, THE PHYSICIAN COULD NOT INJECT. A CATHETER OCCLUSION AT THE PUMP CONNECTOR WAS REPORTED. HE DISCONNECTED THE CATHETER FROM THE PUMP CONNECTOR AND WAS ABLE TO ASPIRATE THE CATHETER. HE WAS INITIALLY UNABLE TO FLUSH THE CATHETER ACCESS PORT. WHEN HE APPLIED MORE PRESSURE, IT WAS NOTED THAT FLUID WENT THROUGH. HE RECONNECTED THE CATHETER AND WAS ABLE TO ASPIRATE AND FLUSH. A DYE STUDY WAS COMPLETED AND THE CATHETER WAS CONFIRMED TO BE IN THE CORRECT PLACE. THERE WAS DRUG ADDED TO THE PUMP- MORPHINE 2 MG/ML AT 0.5 MG/DAY AND BUPIVICAINE 2 MG/ML AT 0.5 MG/DAY. THE PATIENT HAD EXPERIENCED UNDERDOSE SYMPTOMS AND WENT THROUGH WITHDRAWAL. THE PATIENT STATUS WAS "ALIVE WITH INJURY." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171717 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention