BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3833571 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09648
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING A CODE ON THE PERSONAL THERAPY MANAGER OF ¿8254.¿ IT WAS UNKNOWN WHAT THE DRUG SYSTEM WAS DELIVERING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAD AN ADJUSTMENT MADE PRIOR TO THE PUMP REFILL DATE. THEY INADVERTENTLY DID NOT CHANGE THE NEXT APPOINTMENT DATE. PATIENT WAS SCHEDULED TO GET A REFILL ON (B)(6) 2014, BUT THE LOW RESERVOIR CODE CAME UP A DAY BEFORE THAT ((B)(6) 2014). PUMP NEVER WENT DRY AND THE PATIENT WAS REFILLED AS SCHEDULED WITH NO ISSUES. THERE WAS NO PATIENT INJURY, NO DEVICE MALFUNCTION. IT WAS NOTED THAT REFILL WAS NORMAL. PATIENT WAS FILLED WITHOUT INCIDENT AND EVERYONE WAS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DYE STUDY WAS DONE ON THE PATIENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309995 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR