BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4942440 · Received July 27, 2015

    Report

    Report Number
    3004209178-2015-14097
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 13, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2015, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE FOLLOWING A TRIP TO A HIGHER ALTITUDE OF ABOUT 9,000 FEET. THE HCP (HEALTHCARE PROFESSIONAL) STATED THAT SHE BELIEVED THAT THE PATIENT'S SYMPTOMS WERE "HIGHLY LIKELY" CAUSED BY SOMETHING ELSE BUT THE PATIENT HAD READ HOW THE PUMP FLOW RATE CAN BE AFFECTED BY HIGH ALTITUDE. THE PATIENT WAS UNSURE IF HIS CHANGE IN BLOOD PRESSURE COINCIDED WITH THE TRIP TO THE HIGHER ALTITUDE. THE DEVICE SYSTEM WAS DELIVERING FENTANYL, CLONIDINE, AND COMPOUNDED BACLOFEN. THE CAUSE OF THE EVENT, INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    THE PATIENT TRAVELED TO A HIGHER ALTITUDE AND WHEN HE RETURNED HOME THE SYMPTOMS RESOLVED. SHE STATED THAT THEY DID NOT PERFORM ANY DIAGNOSTICS OR INTERVENTIONS AS THE ISSUE WAS RESOLVED BY THE TIME THAT THE PATIENT WAS SEEN IN THEIR OFFICE FOR HIS NORMAL REFILL. THE CAUSE OF THE ISSUE IS UNKNOWN, AND HAS CURRENTLY RESOLVED FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487999 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR