BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2897150 · Received January 4, 2013

    Report

    Report Number
    3004209178-2013-00158
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 6, 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

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSSIBLE KINK WAS FOUND IN THE PATIENT'S CATHETER. THERE WAS A CATHETER REVISION IN (B)(6) AND THE PATIENT INITIALLY HAD SOME RELIEF, BUT LATER THE SYSTEM SEEMED TO LOSE EFFECTIVENESS. THIRTEEN DAYS LATER, IT WAS REPORTED THAT, DURING AN OFFICE VISIT ON (B)(6), THE PATIENT HAD HIS PUMP RATE INCREASED. AT THAT TIME, HE WAS FEELING GREAT; HOWEVER, A COUPLE DAYS LATER HE BEGAN USING 25MCG/HR FENTANYL PATCHES ON HIS BACK AGAIN. IT WAS NOTED THAT THIS FOLLOWED AN INCREASE IN THE PATIENT'S ACTIVITY LEVEL. THE PATIENT'S DOSE WAS THEN INCREASED. IT WAS FURTHER REPORTED THAT THE PAIN HAD BEGUN FOLLOWING SURGERY. ON (B)(6), THE PATIENT WAS REPORTEDLY HAVING MORE PAIN. THE PAIN WAS LOCATED IN HIS NECK, BILATERAL SHOULDERS, BILATERAL HIPS, AND BILATERAL LOW BACK. IT WAS FOUND THAT THE CATHETER HAD NOT MIGRATED. IT WAS STATED THAT THE PATIENT HAD BEEN "UP AND AROUND CONSIDERABLY MORE THAN USUAL." THE PATIENT'S DOSE WAS INCREASED AGAIN. ON (B)(6), IT WAS REPORTED THAT A CATHETER DYE STUDY HAD BEEN ATTEMPTED, BUT THERE WAS AN INABILITY TO ASPIRATE. DURING AN EXPLORATION OF HIS CATHETER, IT WAS NOTED THAT IT WAS THE DISTAL SEGMENT THAT WAS UNABLE TO BE ASPIRATED. THE DISTAL SEGMENT OF THE CATHETER WAS REPLACED, BUT THE PATIENT STILL DID NOT GET PAIN RELIEF. THE DRUG BEING USED IN THIS SYSTEM WAS DILAUDID. REFER TO MANUFACTURER REPORT #3004209178-2013-00156. THIS PATIENT LATER HAD A REVISION TO THE PROXIMAL SEGMENT OF HIS CATHETER AFTER THERE WAS NO PAIN RELIEF FOLLOWING THE DISTAL SEGMENT REVISION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4060 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R