BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2162075 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05363
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULT OF THE RETURNED CATHETER WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    PT REPORTED LOSS OF PAIN RELIEF AND SYMPTOMS OF WITHDRAWAL. THERE WAS A HISTORY OF RAPID INCREASE IN INTRATHECAL DOSES WITHOUT RELIEF. THERE WERE SHORT-LIVED PERIODS OF RELIEF BUT NOT SUSTAINED. HIS DOSE WAS STABLE AT 10MG/DAY, HOWEVER WHEN THE PUMP WAS INTERROGATED IT WAS INFUSING 19.986 MG OF MORPHINE SULPHATE/DAY. HIS CURRENT PHYSICIAN WAS UNABLE TO ASPIRATE THE CATHETER VIA THE CAP AND HAD DONE A DYE STUDY. THE PT REPORTED NUMBNESS AT THE POCKET SITE AND THE PHYSICIAN SUSPECTED DRUG (BUPIVICAINE) INTO PUMP POCKET. THE PT WAS RECEIVING MORPHINE 30MG/ML AND BUPIVICAINE 1 MG/ML VIA THE PUMP. A CATHETER REVISION WAS DONE ON (B)(6) 2011. DURING REVISION, THERE APPEARED TO BE A GOOD CSF BACK FLOW AFTER THE SC CONNECTOR PORTION WAS REMOVED FROM THE EXISTING CATHETER. THERE WAS NO APPARENT DISRUPTION IN THE CATHETER, BUT AS A PRECAUTION THE PROXIMAL SECTION OF THE CATHETER WAS REPLACED. AT THE TIME OF REVISION, THE EXPECTED RESERVOIR VOLUME WAS 0.3ML AND THE ALARM WAS ACTIVATED. THE ACTUAL VOLUME WAS 1 ML. THE PUMP WAS FILLED WITH SALINE AND PROGRAMMED TO INFUSE AT MINIMUM RATE. ON (B)(6) 2011, THE PT HAD A PUMP REFILL THAT WAS THEN PROGRAMMED TO INFUSE 2.498 MG/DAY OF THE PRESCRIBED DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# UNKNOWN| IMPLANTED: