BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3793948 · Received May 6, 2014

    Report

    Report Number
    3004209178-2014-08602
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 14, 2014
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8870, PRODUCT TYPE: SOFTWARE. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE PATIENT¿S PUMP REPLACEMENT ON (B)(6) 2014, HE HAD INCREASED SPASTICITY. ON THE DATE OF THIS REPORT, THE HEALTH CARE PROVIDER (HCP) HAD THE PATIENT AND FAMILY COME IN FOR A DOSING INCREASE AND TO CHECK THE PUMP TO RULE OUT ANY ALARMS. WHEN THE HCP INTERROGATED THE PUMP, HE GOT AN ATTENTION DIALOGUE BOX SHOWING A PUMP MEMORY ERROR (PME)/ DRUG INFUSION DATA INVALID. THE VERSION SOFTWARE WAS NOTED TO BE (B)(6). THE HCP HAD NOT CHECKED FOR A VOLUME DISCREPANCY OR PERFORMED ANY DIAGNOSTIC TESTING. THE HCP CREATED A PRINT REPORT AND SENT IT TO THE DEVICE MANUFACTURER DURING THE REPORT. THE REPORT SHOWED THE PME AND DRUG INFUSION DATA VALID. THE PUMP LOGS SHOWED NO ALARM. THE ESTIMATED ERI (ELECTIVE REPLACEMENT INDICATOR) WAS READING ¿?? MONTHS¿. THE HCP WAS LATER CONTACTED AGAIN AND WAS TOLD TO UPDATE THE PUMP. THE HCP INCREASED THE DOSE AND THEN UPDATED THE PUMP. HE THEN REINTERROGATED THE PUMP AND THE PME AND DRUG INFUSION DATA IS INVALID MESSAGE CLEARED. THE HCP ALSO REPORTEDLY PROVIDED A COPY OF THE FINAL PRINTOUT HOWEVER BOTH PRINTOUTS PROVIDED, THE FIRST BEING WHEN THE PUMP WAS READ ON THE REPORT DATE AT 11:38AM HAD THE PME AND ¿DRUG INFUSION DATA IS INVALID¿ MESSAGES AND THE SECOND PRINTOUT FROM 12:05PM HAD BOTH MESSAGES STILL AS WELL AS THE ¿ESTIMATED ERI ?? MONTHS¿ STILL. IT WAS LASTLY NOTED THE PATIENT HAD SEEN THE SURGEON SINCE THE REPLACEMENT AND THERE WAS ¿SOME IMAGING STUDIES¿ THAT WERE DONE WHICH THE SURGEON ¿THOUGHT LOOKED OKAY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. THREE DAYS LATER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED AGAIN THAT THE PME MESSAGE OCCURRED UPON INTERROGATION. NO EMI (ELECTROMAGNETIC INTERFERENCE) WAS NOTED TO HAVE BEEN INVOLVED. IT WAS REPORTED THE PATIENT WAS NOW DOING BETTER WITH A DOSE INCREASE MADE. NO DEVICES WERE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270895 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR