BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3821864 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09302
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 29, 2014
    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

    ANALYSIS OF THE PUMP FOUND MOTOR GEAR TRAIN ANOMALY, CORROSION AND/OR WEAR AND/OR LUBRICATION. ANALYSIS OF THE PUMP ALSO FOUND MOTOR GEAR ANOMALY STALL DUE TO GEAR WHEEL 3. ANALYSIS OF THE PUMP ALSO FOUND PUMP ALARM ANOMALY AND RESONATOR ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709PTO, LOT # J0058233R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT # N157725, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN A MOTOR STALL AND THE PUMP WAS SUBSEQUENTLY REPLACED. IT WAS ALSO NOTED THAT A DYE STUDY HAD BEEN PERFORMED BECAUSE IT WAS FELT THAT THE PUMP WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300311 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention