BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2897171 · Received January 4, 2013

    Report

    Report Number
    3004209178-2013-00156
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    March 12, 2018
    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

    (B)(4). ANALYSIS OF THE CATHETER FOUND THAT THERE WERE INDENTATION CUTS OR TEARS IN THE SEALING SURFACE OF THE SUTURELESS CONNECTOR CUP. THERE WAS ALSO A WELL DEFINED INDENT OUTSIDE THE CATHETER LUMEN AREA. THESE MAY BE THE CAUSE OF THE OCCLUSION. THERE WAS NO LEAK SEEN DURING THE PRESSURE TESTING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6). PRODUCT TYPE CATHETER. (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

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE (B)(6) DOES NOT APPLY TO (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT DURING THE PATIENT'S FIRST REFILL AFTER THE PREVIOUS REVISION THE HEALTH CARE PROFESSIONAL WAS UNABLE TO FILL THE PUMP WITH THE EXPECTED AMOUNT OF DRUG. ONLY 13 ML OF DRUG WAS ABLE TO FIT IN THE PUMP. THE NEEDLE WAS REPOSITIONED, BUT THE PUMP STILL WOULD NOT ACCEPT ANY MORE DRUG. WHEN THE HCP HAD INITIALLY ASPIRATED THE PUMP HE HAD NOTED THAT HE DREW OUT BUBBLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY DURING THE PATIENT'S FIRST REFILL AFTER REVISION. THE EXPECTED RESIDUAL VOLUME (ERV) WAS APPROXIMATELY 2.2ML, WHERE THE ACTUAL RESIDUAL VOLUME (ARV) WAS APPROXIMATELY 10ML. THIRTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING THERAPEUTIC RELIEF. ASPIRATION HAD BEEN ATTEMPTED, BUT HAD FAILED. IT WAS STATED THAT PART OF THE CATHETER HAD BEEN REPLACED DUE TO AN UNKNOWN OCCLUSION. AFTER REVISION, IT STILL WASN'T POSSIBLE TO PUSH FLUID THROUGH THE EXPLANTED SEGMENT OF THE CATHETER. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY DURING THE PROCEDURE AND HE RECOVERED WITHOUT SEQUELA. THE SAME DAY, ANOTHER REPORT STATED THAT THE PATIENT WAS BROUGHT IN TO HAVE A CATHETER DYE STUDY ON (B)(6). THE "SIDE PORT" WAS ACCESSED WITHOUT DIFFICULTY, BUT ASPIRATION WAS UNSUCCESSFUL. IT WAS REPORTED THAT A BOLUS WAS INITIATED, BUT IT WAS NOT DELIVERED. THE PROXIMAL CATHETER WAS THEN DETACHED FROM THE PUMP TO BE DIRECTLY ASPIRATED, BUT IT WAS STILL UNSUCCESSFUL. IT WAS ALSO NOTED THAT INJECTION INTO THE CATHETER, THROUGH THE "SIDE PORT" AND THROUGH THE CATHETER ITSELF, WAS UNSUCCESSFUL. IT WAS NOTED THAT UPON REMOVAL OF THE CATHETER, THERE DIDN'T APPEAR TO BE A KINK OR AN OCCLUSION. A NEW PROXIMAL CATHETER WAS DRAWN INTO THE LUMBAR INCISION AND WAS CONNECTED TO THE DISTAL CATHETER. IT WAS REPORTED THAT IT HAD BEEN FULLY ASPIRATED SO THAT IT ONLY HAD SPINAL FLUID IN IT. IT WAS ALSO NOTED THAT THE DISTAL CATHETER APPEARED TO BE IN PLACE. THE DRUG USED IN THIS SYSTEM WAS DILAUDID. 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
    4205 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention