BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3153372 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08914
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    May 13, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PROGRAMMER MODEL: 8835, SERIAL# (B)(4); CATHETER MODEL: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2013 DUE TO RENAL CELL CANCER/CARCINOMA. IT WAS NOTED THERE WERE NO DIAGNOSTIC METHODS PERFORMED AND NO ACTION TAKEN. IT WAS ALSO NOTED THIS WAS A PRE-EXISTING CONDITION, WORSENING OR EXACERBATION. THERE IS NOT INFORMATION TO INDICATE THE DEVICE/INFUSION THERAPY CONTRIBUTED TO THE PATIENT'S INJURY AND/OR DEATH. THE PUMP SYSTEM WAS USED TO DELIVER DILAUDID 3.0 MG/ML, BUPIVACAINE 30.0 MG/ML, BACLOFEN 400.0 MCG/ML, CLONIDINE 200.0 MCG/ML, AND DROPERIDOL 300.0 MCG/ML.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EVENT RESULTED IN "IN-PATIENT OR PROLONGED HOSPITALIZATION". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE. DRUGS DELIVERED VIA THE DEVICE WERE DILAUDID, DROPERIDOL AND BACLOFEN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258694 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization