BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2883202 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12149
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    February 26, 2012
    Report Date
    November 21, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS BEING SEEN FOR THE FIRST TIME BY THE HEALTHCARE PROVIDER (HCP) ON (B)(6)2012. THEY WERE REFILLING THE PUMP WITH MORPHINE AND BUPIVACAINE AND SAW A MOTOR STALL ON INTERROGATION. THE HCP READ THE LOGS AND THERE WAS A MOTOR STALL ON (B)(6) 2012 AND TUBE SET ALARM ON (B)(6) 2012, BUT NO RECOVERY RECORDED. THE LOGS ALSO SHOWED A REFILL WAS DONE ON (B)(6) 2012 WITH 10ML OF SALINE. IT WAS NOTED THAT THE PATIENT DID NOT HAVE AN MRI BACK IN (B)(6), BUT HAD HAD A CAT SCAN; THE DATE OF THE CAT SCAN WAS NOT REPORTED. THE HCP HAD THE TELEMETRY FROM THE PRIOR CLINIC AND THERE WAS MENTION OF A MOTOR STALL IN THE LOGS. THE HCP STATED THAT THE PROGRAMMER SAID THERE SHOULD BE 7.9ML OF SALINE AND THAT'S WHAT THEY ASPIRATED. THE PHYSICIAN CHOSE NOT TO PRIME THE CATHETER AND PUMP TUBING, SO IT WOULD TAKE UNTIL THE END OF THE NEXT WEEK BEFORE THE PATIENT STARTED RECEIVING THE DRUG. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WAS NOT HAVING THERAPEUTIC EFFECT/NOT GETTING ANY RELIEF. THE PUMP WAS STILL SAYING IT WAS STALLED AND WAS ALARMING. THE PUMP HAD NOT BEEN ACCESSED TO SEE IF IT WAS INFUSING. REVIEW OF THE LOGS CONFIRMED ONLY THE ONE MOTOR STALL ON (B)(6) 2012 WITH NO RECOVERY RECORDED. THIS REPORTER STATED THAT THE NOTES INDICATED THAT WHEN THE PUMP WAS FILLED IN APRIL BY THE PREVIOUS CLINIC, 18ML OF SALINE WAS PUT INTO THE PUMP RATHER THAN THE 10 THAT HAD BEEN PREVIOUSLY REPORTED AND THAT IN NOVEMBER THE PHYSICIAN DREW OUT 17ML OF SALINE RATHER THAN THE 7.9 THAT WAS PREVIOUSLY REPORTED. THE PHYSICIAN WANTED TO REPLACE THE PUMP AND CHECK THE CATHETER AT THAT TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE MOTOR WAS STILL UNKNOWN. AT THE TIME OF REPORT, NO ADDITIONAL TROUBLESHOOTING HAD BEEN PERFORMED. A REPLACEMENT PROCEDURE WAS TO BE SCHEDULED AS SOON AS POSSIBLE, THOUGH NO SPECIFIC DATE WAS GIVEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Required Intervention