BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4683811 · Received April 13, 2015

    Report

    Report Number
    3004209178-2015-07106
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Report Date
    March 20, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS EXPERIENCING BACK PAIN. THE 8870 CARD WAS GIVEN TO A MANUFACTURER¿S RE PRESENTATIVE FOR UPDATE. THE OLD SOFTWARE REQUIRED A CATHETER VOLUME TO UPDATE THE REFILL VOLUME OF THE RESERVOIR. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE HEALTHCARE PROFESSIONAL (HCP) NOTED THAT THE PATIENT WAS ON HOSPICE AT HOME. THE PUMP WAS USED TO INFUSE COMPOUNDED MORPHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP MEMORY ERROR OCCURRED DURING AN UPDATE OR INTERROGATION. THE REPORTER STATED HE WAS WORKING WITH ¿HIS OLDER PROGRAMMER¿ WHICH DID NOT RECOGNIZE THE ASCENDA CATHETER. THE REPORTER SWITCHED THE CATHETER TO ¿OTHER¿ ON THE PROGRAMMER SO HE WAS ABLE TO UPDATE THE PUMP WITH A SMALL DOSE INCREASE. THE PATIENT WAS IN FOR A REFILL ¿LAST FRIDAY¿ ((B)(6) 2015) BUT HE DID NOT HAVE A PROGRAMMER THAT TIME SO THEY HAD NOT BEEN ABLE TO UPDATE THE PUMP. THE REPORTER WANTED TO UPDATE THE RESERVOIR VOLUME AND MAKE A SMALL DOSE ADJUSTMENT ON THE DATE OF THIS REPORT. THE PUMP WAS USED TO INFUSE MORPHINE (UNKNOWN). NO INTERVENTION OR OUTCOME WAS REPORTED FOR THIS EVENT. FOLLOW UP WAS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THORACOLUMBAR SPINE PAIN. THE 8840 PROGRAMMER WAS GIVEN TO A MANUFACTU RER¿S REPRESENTATIVE FOR THE 8870 SOFTWARE UPDATE. THE CATHETER VOLUME ENTERED WAS 0.4ML, NO BOLUS OR CHANGES IN THE DRUG CONCENTRATION WERE DONE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245978 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR