BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2862370 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11313
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 13, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8711 LOT# N139297007, IMPLANTED: (B)(6), CATHETER MODEL: 8711, LOT# : J11199R18, IMPLANTED: 2002 (B)(6), EXPLANTED: 2009 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT HAD TO HAVE CATHETER REPLACED EVERY YEAR FOR THE PAST 3 YEARS" (MANUFACTURER REPORT # 6000030-2008-02145 AND 3004209178-2010-02678 HAVE REPORTED PREVIOUS TWO CATHETER REVISIONS). PER MFR DEVICE REGISTRATION SYSTEM PATIENT HAD A CATHETER REPLACED IN 2009. THE FOLLOWING INFORMATION REGARDING THE 2009 CATHETER EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT # 3004209178-2012-09572: [IT WAS ALSO REPORTED THAT THE PATIENT HAD TO HAVE THE CATHETER REPLACED "EVERY YEAR FOR THE PAST 3 YEARS" (REFER TO MANUFACTURER REPORT # 6000030-2008-02145 AND 3004209178-2010-02678).] ANY ADDITIONAL INFORMATION RECEIVED REGARDING THE 2009 CATHETER REPLACEMENT WILL BE REPORTED IN THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1