BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2913014 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00504
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 1999, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (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

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ANALYSIS OF THE CATHETER ((B)(4)) REVEALED A NON-SIGNIFICANT INDENT IN THE SC CONNECTOR SEAL, WHICH WAS NOT THOUGHT TO HAVE AFFECTED INFUSION. ANALYSIS OF THE CATHETER ((B)(4)) REVEALED THE CATHETER WAS RETURNED IN SEGMENTS. THE CATHETER PASSED ALL ACCEPTABLE TESTING. PREVIOUSLY REPORTED RESULTS CODE 1023 NO LONGER APPLIES TO THIS EVENT.

    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 POCKET INFECTION OCCURRED. THE PUMP AND CATHETER WERE REMOVED. THE PATIENT WAS NOTED TO HAVE HAD NO INJURY AND RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20145 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention