BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3950687 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13368
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER; PRODUCT ID 8835, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE CAUSE OF THE PROGRAMMING ISSUE WAS THE HCP PROGRAMMED TOO HIGH OF A DOSE. PER THE REPORTER THERE WAS NO PROGRAMMING MISTAKE THAT LEAD TO THE PROGRAMMING OF THE TOO HIGH OF A DAILY DOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1-2 WEEKS PRIOR TO THIS REPORT, THE PATIENT WAS RECEIVING TOO MUCH DRUG. THE DOSE WAS CUT IN HALF, BUT THEN 2 DAYS PRIOR TO THIS REPORT, THE PATIENT WAS HAVING MORE BREAKTHROUGH PAIN, SO THEY WERE CHANGING THE PA (PATIENT ACTIVATED) PROGRAMING FROM ¿MAX: 4 TO 6 AND INTL: 4HR TO 3HR AND THE DRI: 1/4HR TO 1/3HR¿. IT WAS NOTED THAT THE PATIENT HAD 2 PTMS (PATIENT THERAPY MANAGERS). THE DEVICE SYSTEM WAS DELIVERING FENTANYL AND CLONIDINE. IT WAS LATER REPORTED THAT THE PATIENT WAS DROWSY AND LETHARGIC WHEN SHE WAS RECEIVING TOO MUCH MEDICATION. THE CAUSE OF THE PATIENT¿S SYMPTOMS WERE NOTED TO BE RELATED TO THE PROGRAMMING; TOO HIGH OF A DAILY DOSE WAS PROGRAMMED WITH HER MEDICATION. THE PATIENT HAD NO ISSUES SINCE REPROGRAMMING. THE PATIENT WAS DOING MUCH BETTER AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428771 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention