BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3100043 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07389
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 12, 2013
    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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 8711 LOT # (B)(4) AND 8709 SERIAL NUMBER (B)(4) CATHETERS FOUND BOTH WERE INCOMPLETE/ RETURNED IN SEGMENTS AND REVEALED ACCEPTABLE TESTING. ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8711, LOT# J11387R48, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A CATHETER ISSUE OCCURRED. THE CATHETER HAD NO RETROGRADE FLOW DURING A PUMP REPLACEMENT, IT WAS NOTED IT WAS AN "UN KNOWN ISSUE". THE LOCATION OF THE ISSUE WAS THE CATHETER TRACK. THE CATHETER WAS REPLACED. THE PATIENT HAD REPORTEDLY EXPERIENCED LESS THAN FIFTY PERCENT OF THERAPY RELIEF. THE DEVICE SYSTEM ADMINISTERED LIORESAL. THE PATIENT WAS REPORTEDLY ALIVE WITHOUT AN INJURY OR ADVERSE EVENT AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201687 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention