BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2810313 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09766
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 4, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS MISSED REFILL WHILE THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "OTHER HEALTH ISSUES" IN ADDITION TO A POSSIBLE URINARY TRACT INFECTION (UTI). THE PATIENT USUALLY GETS PUMP REFILLED AT HOME, THEREFORE MISSED A REFILL. THE USUAL ORGANIZATION WAS UNABLE TO FILL THE UNTIL PUMP MID-MONTH. AS OF THE REPORT DATE, IT WAS BELIEVED THAT THE PUMP WAS EMPTY AND THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) WITH DEVELOPED SYMPTOMS OF TACHYCARDIA AND INCREASE IN RESPIRATORY RATE. THE ICU STAFF WAS WORKING ON GETTING THE PUMP REFILLED. THE MEDICATION IN THE PUMP WAS BACLOFEN. NO OTHER EVENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF 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 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization