BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3853066 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10237
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 19, 2014
    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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT# N115784, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE 8709 CATHETER REVEALED, CATHETER BODY HOLE CAUSED BY DEEP ABRASION. ANALYSIS OF THE 8578 CATHETER REVEALED SC CONNECTOR CORING-TEARS-CUTS IN SEAL.

    Description of Event or Problem · 1

    IT WAS REPORTED A BREAK IN THE PROXIMAL SEGMENT OF THE PATIENT¿S CATHETER WAS IDENTIFIED. AS A RESULT, THE AFFECTED PORTION OF THE CATHETER WAS REMOVED (10 CM). A NEW SC CONNECTOR WAS ADDED. THE CATHETER WAS ASSESSED AND THERE WERE NO OTHER LEAKS NOTED BY THE PHYSICIAN. THE PHYSICIAN FELT THAT THE REST OF THE CATHETER WAS INTACT. THE CAUSE OF THE CATHETER BREAK WAS UNKNOWN, BUT THE ISSUE WAS RESOLVED. THERE WAS NO ALLEGED PRODUCT ISSUE OF THE SUTURELESS PUMP CONNECTOR. IT WAS NOTED THAT AT THE LAST REFILL, THE NURSE NOTED A FLUID LEAK FROM THE INJECTION SITE. THE PATIENT¿S CAREGIVER HAD NOT REPORTED ANY CHANGE IN THE PATIENT¿S HEALTH. DURING A NORMAL PUMP REPLACEMENT PROCEDURE, CLEAR FLUID WAS NOTED IN THE PUMP POCKET. THE DOSE WAS REDUCED BY HALF FROM 608 MCG/DAY TO THE CURRENT SETTING OF 300 MCG/DAY. NEUROLOGY WAS GOING TO BE CLOSELY FOLLOWING THE PATIENT. AS OF THE DATE OF THIS REPORT, THE PATIENT¿S STATUS WAS REPORTED AS ALIVE, NO INJURY. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE CATHETER REVISION. THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333120 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR