BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113728 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03928
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    September 6, 2010
    Report Date
    May 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE PUMP SITE. THE PATIENT'S SYMPTOMS WERE INDURATION, SWELLING, DRAINAGE AT THE PUMP POCKET SITE. THE EVENT RESULTED IN THE PATIENT BEING HOSPITALIZED. THE PATIENT'S INFECTION WAS TESTED ON (B)(6) 2010. THE TEST RESULTS WERE (B)(6). THE PATIENT'S PUMP WAS REMOVED ON (B)(6) 2010. THE EVENT WAS ONGOING. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2011 DUE TO STAGE IV LUNG CANCER. THE DRUGS IN THE PUMP AT THE TIME OF THE EVENT WERE MORPHINE 16.1MG/ML DELIVERED AT 6.408MG/DAY, BUPIVACAINE 12.3MG/ML DELIVERED AT 4.895MG/DAY, AND FENTANYL 2,000MCG/ML DELIVERED AT 796.0MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REGARDING THE INFECTION THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R CATHETER: MODEL 8596SC, LOT# N196553009| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N193501001| EXPLANTED: