BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2853596 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11029
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 28, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8590-9 LOT# N258008, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD INCORRECTLY PERFORMED A BRIDGE BOLUS. IT WAS INDICATED THAT THE PHYSICIAN HAD ADDED PRIALT TO THE PUMP BUT DID NOT UPDATE THE CONCENTRATION. IT WAS NOTED THAT THE PHYSICIAN WANTED TO STOP THE BRIDGE BOLUS AS IT WAS JUST UPDATED WITHIN 2 MINUTES OF THIS REPORT. IT WAS STATED THAT THE PHYSICIAN HAD WENT BACK IN TO PUT IN THE PROPER CONCENTRATIONS OF THE OTHER DRUGS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE DRUGS DELIVERED VIA PUMP, INCLUDING PRIALT WERE SUFENTANIL, CLONIDINE, AND BUPIVACAINE. ADDITIONAL INFORMATION HAD 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