BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232735 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11932
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER; PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT, THE PATIENT HAD BEEN VERY COMFORTABLE WITH NO PROBLEMS. THE PATIENT CAME IN FOR A REFILL AND THE EXPECTED RESERVOIR VOLUME WAS 24ML; THE ACTUAL AMOUNT WAS 37ML. THE PATIENT WAS STILL COMFORTABLE AND WASN¿T EXPERIENCING ANY WITHDRAWAL SYMPTOMS. THE PATIENT DID NOT HAVE ANY ORAL MEDICATION, SO WAS NOT SUPPLEMENTING. THE WITHDRAWN DRUG LOOKED NORMAL. THEY VERIFIED THE NEEDLE POSITION UNDER X-RAY BEFORE REMOVING IT FROM THE PORT. THEY THEN FILLED IT WITH MEDICATION AND WITHDREW THE MEDICATION BACK AGAIN TO MAKE SURE THEY WERE STILL IN THE RESERVOIR AND IT ALL CAME BACK OKAY. THE LAST PUMP REFILL WAS (B)(6) 2013; THE PUMP WAS FILLED WITH 39ML. AT THAT TIME, THE VOLUMES WERE ACCURATE. THE PUMP LOGS WERE REVIEWED AND LOOKED NORMAL. THE PHYSICIAN WAS PLANNING TO DO A DYE STUDY. THE PUMP WAS DELIVERING MORPHINE 15 MG/ML AT APPROXIMATELY 3 MG/DAY AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE FLOW WAS LOST FROM THE CATHETER. A REVISION WAS DONE ON (B)(6) 2013. THE PHYSICIAN DECIDED TO DECREASE THE MORPHINE DOSE DOWN TO 1MG/DAY AND NOT PRIME THE CATHETER BECAUSE, THE PHYSICIAN WAS NOT CERTAIN THAT ALL OF THE DRUG HAD BEEN ASPIRATED FROM THE CATHETER. THE PATIENT WAS DOING FINE. THE PATIENT WAS GOING TO BE ASSESSED THROUGH THE OVERNIGHT. 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
    333367 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention