BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3873871 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11601
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS APPLICABLE FOR THE FIRST SUPPLEMENTAL REPORT THAT WAS PREVIOUSLY SUBMITTED ON 2014-12-22.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6), PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N238378, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE PUMP WAS RETURNED WITH THE RESERVOIR EMPTY AND RUNNING IN SIMPLE CONTINUOUS INFUSION MODE WITH PA DOSE ACTIVE. PUMP LOGS GATHERED. DISPENSE TESTING PASSED. INFUSION CHARACTERIZATION TEST DONE. SEPTUM WAS TESTED WITH NO ANOMALIES FOUND. DESTRUCTIVE ANALYSIS PERFORMED WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S MOTHER ¿THINKS PUMP MAY BE OVER INFUSING. NO SPECIFIC INFO JUST SOME DAYS HER THERAPY IS GOOD, OTHER NOT. NO VOLUME ISSUES AT REFILLS¿. ACTIONS REQUIRED AS A RESULT OF THE EVENT CONSISTED OF REPLACEMENT ON (B)(6) 2014 HOWEVER THE DEVICE MANUFACTURER IMPLANT REGISTRY SYSTEM LISTED (B)(6) 2014. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD BEEN PERFORMED. IT WAS NOTED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN 500MCG/ML AT A DOSE OF 258MCG PER DAY. 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
    352276 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention