BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2150967 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04622
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    December 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER MODEL 8709SC, LOT# N276875013 SHOWED A PROCEDURAL NON-CONFORMANCE. THE CATHETER WAS PATENT WITH NO LEAKING SEEN. THERE WERE TEARS/CORING SEEN IN THE CUP OF THE SUTURELESS CONNECTOR (SC), BUT NO LEAKS. THERE WAS AN INDENT DOWN IN THE CUP OF THE SC CONNECTOR THAT WAS COMPLETELY OFFSET TO THE LUMEN OF THE CATHETER.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED WITH AN ACTUAL RESIDUAL VOLUME OF 18ML AND AN EXPECTED RESIDUAL VOLUME OF 2ML. THERE WERE NO SYMPTOMS OF WITHDRAWAL OR OVERDOSE. A DYE STUDY WAS BEING PLANNED. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT PATIENT WAS NOT GETTING THERAPY. ON ATTEMPTING A DYE STUDY UNDER FLUORO, AN APPARENT KINK IN THE CATHETER WAS NOTED AND THE HCP WAS UNABLE TO ASPIRATE OR INJECT THE DYE. AT THE TIME OF REFILL, PATIENT HAD 18MLS OF DRUG REMOVED FROM THE PUMP RESERVOIR WHILE THE EXPECTED VOLUME WAS 2 MLS. DURING REVISION, THE SPINAL SEGMENT OF THE CATHETER WAS REPLACED WITH ANOTHER (B)(4) AND ON CUTTING THE EXISTING DISTAL END THERE WAS CUT GOOD CEREBROSPINAL FLOW. THE PROXIMAL PUMP SEGMENT WAS ACCESSED VIA THE CAP (CATHETER ACCESS PORT) AND THE PHYSICIAN WAS ABLE TO PUSH DYE VIA THE CAP. HE ALSO SEPARATED THE SUTURELESS CONNECTOR AND WAS ABLE TO ASPIRATE AND PUSH DYE THROUGH THE PROXIMAL SEGMENT BUT WHEN HE ATTEMPTED TO ASPIRATE AND FLUSH THE SUTURELESS CONNECTOR HE WAS UNABLE TO DO SO. THE EVENT DATE WAS REPORTED AS (B)(6) 2011. PATIENT OUTCOME WAS STATED AS RECOVERED WITHOUT SEQUELAE FOLLOWING REVISION.

    Description of Event or Problem · 1

    THE PATIENT'S PUMP CONTAINED MORPHINE AT A CONCENTRATION OF 15.0 MG/ML AND DOSAGE OF 4.502 MG/DAY.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N276875013| IMPLANTED:| EXPLANTED: