BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3870696 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11526
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 22, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) DID A SIDE PORT ACCESS OF THE CATHETER TODAY AND FOUND A PROBLEM. IT WAS STATED THEY WERE PLANNING TO DO A REVISION THE DAY OF REPORT SINCE THE PATIENT WAS GOING THROUGH WITHDRAWAL. THE DRUG DELIVERED IN THE PUMP WAS UNKNOWN. PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348443 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention