BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191298 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10931
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE CATHETER REPLACED. THE PATIENT¿S PUMP WAS FLIPPED, AND THE CATHETER WAS BROKEN. THE REPORTER PROVIDED PHOTOGRAPHS OF THE PUMP AND CATHETER AS IT APPEARED WHEN REMOVED, AND PER OBSERVATION THE CATHETER ALSO HAD TWISTING IN ADDITION TO THE BREAK. THE CATHETER WAS NOT GOING TO BE RETURNED. 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
    290870 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention