BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4669792 · Received April 8, 2015

    Report

    Report Number
    3004209178-2015-06210
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MEDTRONIC 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED ACCEPTABLE CATHETER TESTING. IT WAS NOTED THAT AN INCOMPLETE CATHETER WAS RETURNED. THE CATHETER WAS RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); EXPLANTED: 2015 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF LESS THAN 50% THERAPY RELIEF. THERE WAS A CATHETER FAILURE OF NOT BEING ABLE TO ASPIRATE THE SIDE PORT DURING A DYE STUDY. THE LOCATION OF THE CATHETER ISSUE WAS UNKNOWN. A CATHETER REVISION/EXPLORATION WAS PERFORMED. THE CATHETER WAS REMOVED AFTER FURTHER ATTEMPTS TO ASPIRATE FAILED INTRA-OPERATIVELY. THERE WERE NO OBVIOUS KINKS OR CRACKS NOTED BY THE IMPLANTING PHYSICIAN. A NEW CATHETER WAS INSERTED IN THE USUAL MANNER, AND THERE WAS GOOD ASPIRATION AT FOUR CHECKS INTRA-OPERATIVELY. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE PUMP SYSTEM WAS BEING USED TO INFUSE DILAUDID. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231850 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention