BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4219491 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20794
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8578, LOT# N140582, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8711, LOT# J0058220R, IMPLANTED: 2002 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S PUMP WAS EXPLANTED SIX YEARS AGO DUE TO INFECTION. THE PATIENT COULD NOT RECALL THE DATE. THE DATE/ONSET OF THE INFECTION, WHETHER OR NOT THE PATIENT EXPERIENCED ANY SYMPTOMS RELATED TO THE INFECTION, THE ACTIONS TAKEN TO RESOLVE THE ISSUE, THE PATIENT¿S OUTCOME, AND THE TYPE OF DRUG DELIVERED AT THE TIME OF THE EVENT REMAINS UNKNOWN. FOLLOW-UP WAS PERFORMED TO OBTAIN THIS INFORMATION. IF THIS INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701494 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention