BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162523 · Received June 11, 2013

    Report

    Report Number
    3007566237-2013-01926
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 11, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER; PRODUCT ID 8591-38, LOT# D25456, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT¿S PUMP CONTAINED INFUMORPH 20MG/ML AND MARCAINE 10MG/ML. THE PUMP WAS FILLED WITH 20ML OF DRUG. ONE TO TWO WEEKS LATER, IT WAS FOUND THAT 20ML WAS STILL IN THE PUMP. NO DRUG WAS BEING DELIVERED. THE PATIENT EXPERIENCED PAIN AND LOSS OF THERAPY. NO CAUSE WAS DETERMINED. A NEW CATHETER WAS IMPLANTED ON 6/17/2013. THE OLD CATHETER REMAINED IMPLANTED AND WAS TIED OFF. IT WAS SUSPECTED THAT THERE WAS A PROBLEM WITH THE OLD CATHETER GETTING KINKED. AFTER THE NEW CATHETER WAS IMPLANTED, THE PATIENT WAS DOING WELL AND WAS GETTING GOOD THERAPY. IT WAS LATER REPORTED THAT, PRIOR TO THE CATHETER REPLACEMENT, THE PATIENT¿S PUMP WAS DELIVERING INFUMORPH 20MG/ML AT 3.998MG/DAY AND BUPIVICAINE 10MG/ML AT AN UNKNOWN DAILY DOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP FAILED; THE PHYSICIAN WAS GETTING 20 CC OF MEDICATION BACK ON ASPIRATION WHICH WAS MORE THAN EXPECTED. A DYE STUDY WAS BEING CONSIDERED. THE PATIENT WAS NOT RECEIVING GOOD THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262586 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention