BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3981882 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13993
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8590-1, LOT # N323671, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING BLACK OUTS, MEMORY LOSSES, AND SHOWING UP AT PLACES SHE DIDN'T REMEMBER BEING. THE PATIENT REPORTEDLY HAD SWELLING IN BOTH HER LEGS AND FEET. IT WAS NOTED THAT THIS HAD BEEN GOING ON SINCE IMPLANT, AND HAD BEEN GETTING WORSE OVER THE LAST COUPLE OF MONTHS. THE PATIENT REPORTEDLY SPOKE WITH THEIR HEALTHCARE PROFESSIONAL (HCP) REGARDING THESE ISSUES, BUT THE HCP STATED THAT IT WAS NOT RELATED TO THE PATIENT'S PUMP. THE PATIENT RECENTLY SAW A NEUROLOGIST WHO STATED THAT THE PATIENT HAD SPOTS ON HER BRAIN LIKE THE PATIENT WAS HAVING EITHER MINI-STROKES OR TRANSIENT ISCHEMIC ATTACKS OR SOMETHING. IT WAS NOTED THAT THERE WERE OVER ONE HUNDRED OF THEM AND THAT COULD BE PART OF THE CAUSE OF THE ISSUES THE PATIENT WAS HAVING. THE PUMP WAS DELIVERING DILAUDID, AND THE PATIENT'S FAMILY THOUGHT THE PUMP COULD BE CAUSING SOME OF THE THINGS THAT WERE GOING ON WITH THE PATIENT. THE HCP HAD REPORTEDLY LOWERED THE PATIENT'S DOSE BY 20%. THE PATIENT'S HCP REPORTEDLY TOLD HER THAT THEY CANNOT TAKE THE PUMP OUT, AND ONCE IT IS IN, ALL THEY COULD DO WAS LOWER IT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457898 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other