BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3032958 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04535
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 5, 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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS OF THE PUMP FOUND PRECIPITATE ON THE FILLPORT SIDE OF THE SEPTUM AS WELL AS ON THE FILLPORT WASHER. IT WAS ALS REPORTED PER SEPTUM, RESERVOIR, OPM AND OPM COVER INSPECTION RESULTS THAT LITTLE TO NO PRECIPITATE WAS SEEN.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, CATHETER: MODEL 8709SC, LOT# N186513022, IMPLANTED: (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A GEAR TRAIN ANOMALY OF THE MOTOR; CORROSION AND/OR WEAR AND/OR LUBRICATION. A STALL DUE TO SHAFT BEARING WAS ALSO FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT ASKED AT A NORMAL REFILL TO HAVE HER PUMP "CHECKED" BECAUSE SHE "DIDN'T FEEL LIKE SHE WAS GETTING RELIEF," HER PAIN WAS "WORSE," BUT THAT SHE DID NOT HAVE WITHDRAWAL SYMPTOMS. ON THE DAY OF THE INITIAL REPORT THE EXPECTED RESIDUAL VOLUME WAS 6.4CC AND THE ACTUAL RESIDUAL VOLUME WAS "OVER 11." LOGS SHOWED MOTOR STALL ON (B)(6) 2013 WITH RECOVERY THE SAME DAY AND ANOTHER STALL ON (B)(6) 2013 AND THEN ON (B)(6) 2013 PUMP STOPPED MAY EXCEED TUBE SET. IT WAS THEN NOTED THAT THE HEALTHCARE PROVIDER (HCP) DOING THE REFILL WAS NOT ABLE TO GET ALL OF THE DRUG INTO THE RESERVOIR, APPROXIMATELY 5MLS WOULD NOT GO IN. THE HCP "GUESSED" THE NEXT STEP WOULD BE TO SCHEDULE SURGERY. THE PATIENT WAS ALSO ON ORAL MEDICATION, THE HCP "THOUGHT" THAT WAS WHY THE PATIENT HAD NOT FELT LIKE SHE WAS IN WITHDRAWAL. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL. THREE WEEKS AFTER THE INITIAL REPORT IT WAS ADDED THAT THE DEVICE HAD BEEN STALLED FOR EIGHT WEEKS. IT WAS NOT NOTED THAT THE OUTCOME WAS OR IF ANY INTERVENTIONS HAD BEEN PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MOTOR STALL HAD NOT RECOVERED AS OF THE DATE OF THIS REPORT. THE PUMP WAS REPLACED. THE PATIENT OUTCOME WAS NOTED AS "ALIVE WITH NO INJURY OR ADVERSE EVENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135766 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention