BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4256083 · Received November 17, 2014

    Report

    Report Number
    3004209178-2014-21725
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    October 1, 2010
    Report Date
    September 20, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2010, THE PATIENT SUFFERED A STROKE AND HAD A BLOOD PRESSURE OF 220/190. IT WAS THOUGHT THAT HIGH BLOOD PRESSURE MIGHT HAVE BEEN DUE IN PART TO EXPERIENCING A HIGH LEVEL OF PAIN. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY SPEAKING DUE TO THE STROKE. IT WAS STATED THAT THE PATIENT'S BLOOD PRESSURE WAS HIGH WHEN HER CATHETER WAS BROKEN [SEE MANUFACTURER REPORT #2182207-2009-03063 AND SUPPLEMENTALS]. THE PATIENT WAS ON BLOOD PRESSURE MEDICATION THAT WAS NOT HELPING WITH THE PAIN AND BLOOD PRESSURE ISSUES. THE PATIENT HAD TO BE CONTINUOUSLY GIVEN POTASSIUM AND BLOOD PRESSURE MEDICATION. IT WAS NOTED THE PATIENT HAD LOW POTASSIUM, HIGH BLOOD PRESSURE, AND A STROKE WITH TWO LESIONS IN THE BRAIN. IT WAS NOTED SHE WENT THROUGH REHABILITATION FOR HER STROKE AND A SECOND PUMP WAS IMPLANTED AT THIS TIME. WHEN THE PATIENT WAS GIVEN ORAL CLONIDINE FOR HIGH BLOOD PRESSURE, THE BURNING PAIN IN HER LEGS WOULD EASE UP. CLONIDINE WAS THEN PUT INTO THE PUMP WITH MORPHINE AND IT EASED THE PATIENT'S NERVE PAIN IN HER LEGS. IT WAS ALSO NOTED THAT THE PATIENT HAD CENTRAL APNEA, WHICH HAPPENED AFTER THE STROKE. IT WAS NOTED THAT AT THE TIME OF THE STROKE, THE PATIENT ONLY HAD MORPHINE IN THE PUMP. THE DOSES AND CONCENTRATIONS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741293 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Other