BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3133509 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08280
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE FOUND PUMP FOUND NO ANOMALY. CATHETER ACCESS PORT TESTING FOUND THE PUMP OUTLET WAS PATENT. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY; THE CATHETER WAS INCOMPLETE/ RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT THROUGH WITHDRAWALS AROUND MID-MARCH 2013. THE PUMP WAS REPLACED DUE TO A PUMP MOTOR STALL. PER THE REPORTER, THE PUMP STOPPED COMPLETELY AND WOULDN¿T WORK AT ALL. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PUMP AND PARTIAL PROXIMAL SEGMENT WERE REPLACED. THE PATIENT HAD EXCELLENT PAIN RELIEF THEN EXPERIENCED SUDDEN WITHDRAWAL SYMPTOMS. A DYE STUDY WAS PERFORMED AND THE HCP (HEALTH CARE PROFESSIONAL) WAS UNABLE TO ASPIRATE OR VISUALIZE THE CATHETER. IN THE OPERATING ROOM, THE SURGEON WAS ABLE TO ASPIRATE THE CATHETER BUT IT WAS DIFFICULT TO SEE THE DYE BEING INJECTED. THE HCP DISCONNECTED THE SC AND PURGED THE CAP (CATHETER ACCESS PORT) AND NOTED A DRIBBLE VERSUS A STREAM. IT WAS ALSO REPORTED THAT THERE WAS AN ISSUE WITH THE SILICONE THAT CONNECTED THE CAP TO THE PUMP. IT WAS THOUGHT THAT THERE WAS AN ISSUE WITH THE SIDEPORT INFUSING INTO CATH. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S DOCTOR TESTED THE PUMP OUTSIDE OF HER BODY TO DETERMINE IT HAD MALFUNCTIONED BUT THE SPECIFIC TEST WAS NOT KNOWN BY THE REPORTER. THE PATIENT WAS EXPECTING A 20 MINUTE CATHETER REVISION BUT AWOKE 2 HOURS LATER AND THE DOCTOR HAD REPLACED THE PUMP BECAUSE THE MOTOR WAS NOT WORKING. THE PATIENT HAD PAIN AND TIME OFF WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234654 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention