BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3953120 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13427
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37092, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8835, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8709SC, LOT# N177541026, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TO PUT THE PTM (PERSONAL THERAPY MANAGER) TOWARDS THE BACK OF THE PUMP TO GET HER BOLUS; WHEN SHE LAID IT DIRECTLY OVER THE PUMP, IT WORKED SOMETIMES. AN ANTENNA WAS ORDERED FOR THE PATIENT. THE PATIENT WAS TO CHECK WITH HER HCP (HEALTH CARE PROFESSIONAL) REGARDING THE PTM PROGRAMMING WITH REGARDS TO LOCKOUT TIME. IT WAS NOTED THAT THE PATIENT FELL A LOT. THE HCP (HEALTH CARE PROFESSIONAL) HAD DONE AN MRI TO CHECK THE CATHETER AND EVERYTHING SEEMED TO BE FINE. THE PATIENT STATED THAT THE PUMP ¿DIDN¿T MOVE MUCH¿. THE DEVICE SYSTEM WAS DELIVERING DILAUDID AND MARCAINE. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED THE ANTENNA. WHEN THE PATIENT TRIED TO GET A BOLUS, SHE GOT A ¿19M¿. THE PATIENT WAS GOING TO TRY AGAIN IN 19 MINUTES. IT WAS NOTED THAT THE PATIENT WAS GETTING THE BOLUSES AND HAD NOT HAD A PROBLEM GETTING LOCKED OUT. IT WAS NOTED THAT THE PUMP HAD ¿MOVED A LITTLE BIT¿; THE PATIENT HAD LOST SOME WEIGHT. SOMETIMES TO BE SUCCESSFUL WHEN READING THE PUMP WITH THE PTM, THE PATIENT NEEDED TO HOLD IT A LONG WAYS FROM THE PUMP IN ORDER FOR IT TO READ IT. WITH THE ANTENNA, SHE WAS OVER THE PUMP, BUT SOMETIMES SHE HAD TO GO ¿OUTSIDE THE PUMP IN ORDER FOR IT TO TAKE¿. ON (B)(6) 2014, THEY CHANGED THE PTM PROGRAMMING SO THAT SHE COULD GET A BOLUS EVERY 4 HOURS; THE NEW LOCKOUTS WERE ¿3 TIMES EVERY TWELVE HOURS AND THE MAXIMUM IS 6" AND "1 BOLUS EVERY 4 HOURS". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430996 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR