BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1983045 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00894
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PHYSICIAN BELIEVED THE PT'S MORPHINE CONCENTRATION AND DOSE WERE HIGH. THE PUMP DELIVERED MORPHINE 25 MG/DL CONCENTRATION. THE PT WAS NOT RESPONDING TO DOSE CHANGES AS EXPECTED. THERE WERE NO NEUROLOGICAL DEFICITS, MOTOR OR SENSORY CHANGES IN THE PT'S LOWER EXTREMITIES. THERE WERE NO BLADDER OR BOWEL FUNCTION CHANGES. THE PUMP AND CATHETER WERE EXPLANTED AND REPLACED. THE REASON FOR THE CATHETER REMOVAL WAS POSSIBLE INTRATHECAL MASS. DURING SURGERY, THE CATHETER WAS EXPLANTED WITH VERY GENTLE PULLING AND THERE WERE NO NEUROLOGICAL CHANGES. THE NEW CATHETER TIP WAS PLACED TWO VERTEBRAL LEVELS FROM THE ORIGINAL CATHETER. THE PT'S MORPHINE DOES WAS WEANED DOWN TO 3 MG/DAY PRIOR TO SURGERY. FOLLOWING SURGERY, THE PT WAS ADMITTED TO THE HOSP FOR OBSERVATION. THE NEW PUMP CONTAINED MORPHINE 10 MG/DL WITH A STARTING DOSE OF 1.5 MG/DAY. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R CATHETER: MODEL 8709, LOT# J0039909R| IMPLANTED:| EXPLANTED: