BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3854253 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10274
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER (SN (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE CATHETER WAS INCOMPLETE AND RETURNED IN SEGMENTS, MET ACCEPTABLE TESTING. A PORTION OF THE CATHETER WAS ATTACHED TO THE DISTAL END OF SEGMENT 2. ANALYSIS OF THE CATHETER (SN (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE CATHETER WAS INCOMPLETE AND RETURNED IN SEGMENTS, MET ACCEPTABLE TESTING. ANALYSIS OF THE CATHETER REFERS TO THE SUTURE-LESS CONNECTOR PORTION OF SEGMENTS 1 AND 2.

    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 THE CATHETERS WERE EXPLANTED DUE TO LOSS OF PAIN RELIEF. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333103 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention