BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1833183 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06915
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    May 24, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS OF THE CATHETER (MODEL 8709SC, (B)(4)) REVEALED THAT TEARS/CUTS/CORING WAS PRESENT WITHIN THE SC CONNECTOR SEAL. THE FOLLOWING WAS NOTED: "DOWN IN THE INSIDE OF THE CUP IS A TEAR AND WHAT LOOKS LIKE SEPARATION OF THE CATHETER TUBING FROM THE TAPERED SEAL." THE CATHETER WAS RECEIVED IN 2 PIECES. ANALYSIS RESULTS OF THE PUMP (MODEL 8637-20, (B)(4)) REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    A PT'S DEVICES WERE EXPLANTED DUE TO THE FACT THAT THERE WAS NO EFFICACY IN REGARDS TO TRYING MULTIPLE DRUGS. THE TYPE OF MEDICATION(S), CONCENTRATION(S), AND DAILY DOSE(S) BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. THE PT HAD RECOVERED WITHOUT ANY ISSUES. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N204191025| IMPLANTED: