BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3852310 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10228
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 14, 2014
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, 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

    ANALYSIS OF THE PUMP, SERIAL NUMBER (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE CATHETER, SERIAL NUMBER (B)(4), FOUND SC CATHETER CONNECTOR DAMAGED AT EXPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER KINK. IT WAS NOTED THAT THE LOCATION OF THE CATHETER ISSUE WAS THE PROXIMAL SEGMENT AND CONNECTOR PIN. IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS SPECIFIED AS PATIENT¿S ABDOMINAL POCKET WHERE PUMP WAS SUTURED IS OBESE AND THEREFORE PUMP MOVES IN POCKET. IT WAS NOTED THAT A PUMP FLIP WAS SUSPECTED, BUT NOT CONFIRMED. IT WAS REPORTED THAT THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED A REVISION/REPLACEMENT. IT WAS NOTED THAT THE PRODUCT ISSUE WAS RESOLVED. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE- NO INJURY. IT WAS REPORTED THAT THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. IT WAS NOTED THAT THE LOCATION OF THE ISSUE OR SYMPTOMS WAS THE DEVICE POCKET. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) REPLACED THE ENTIRE SYSTEM WHEN POCKET WAS OPENED AND CATHETER WAS KINKED. IT WAS REPORTED THAT THE HCP COULD NOT DISCONNECT CATHETER FROM PUMP AND APPEARED TO HAVE BROKEN THE CONNECTOR PIN. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE DILAUDID AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329335 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention