BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3834398 · Received May 28, 2014

    Report

    Report Number
    3004209178-2014-09677
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A ¿SEVERE EVENT¿ WHICH RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE PUMP WAS USED TO DELIVER DILAUDUD, BUPIVACAINE AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT WAS HOSPITALIZED FOR SOMETHING THAT WAS UNRELATED TO THE DEVICE, INFUSION DRUG OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314125 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization