BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3121759 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07958
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    December 1, 2012
    Report Date
    July 25, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703W, LOT# L43521, IMPLANTED: (B)(6) 1997, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A LOWER BACK MAGNETIC RESONANCE IMAGING (MRI) DONE TWO WEEKS AGO AND THE PATIENT WENT BACK TO HIS CURRENT FOLLOW-UP DOCTOR POST MRI TO CHECK THE PUMP STATUS. IT WAS NOTED ¿IT WAS STILL NOT OPERATIONAL THEN.¿ IT WAS ALSO REPORTED ¿IT HAD NOT BEEN WORKING FOR 1.5 YEARS, WAS ALARMING, AND WAS GOING TO BE REPLACED WITH A FORTH PUMP.¿ IT WAS REPORTED THE PUMP WAS EMPTY NOW AND THE OLD DRUG WAS FENTANYL WITH A SMALL DOSE/AMOUNT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER ON 13-NOV-2015. IT WAS REPORTED THAT THE PATIENT HAD A MALFUNCTIONING PUMP IN 2014. THE PATIENT WAS LOOKING FOR A NEW PAIN MANAGEMENT PHYSICIAN AND HE HAD A NEUROSURGEON LINED UP TO REMOVE THE PUMP ONCE HE FOUND A PAIN MANAGEMENT PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD MOVED TO A DIFFERENT STATE AND HAD TRANSFERRED HIS CARE. THE PUMP WAS INTERROGATED WHICH REVEALED THE LOW AND EMPTY RESERVOIR ALARMS. THE PATIENT WAS LAST REFILLED ON (B)(6) 2013 AND THE RECENT EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2013. IN ADDITION, THIS PUMP HAD NUMEROUS MOTOR STALLS AND RECOVERIES SINCE (B)(6) 2013. THE LAST STALL OCCURRED ON (B)(6) 2013 AT 03:36 WITH A TUBE SET ON (B)(6) 2013 AND NO RECOVERY STILL AT THE TIME OF THIS REPORT. REPORTEDLY, THE PATIENT HAD NOT BEEN EXPOSED TO ENVIRONMENTAL FACTORS ON THIS DATE. THE PATIENT WAS REPORTED AS ASYMPTOMATIC. THIS DEVICE SYSTEM DELIVERED FENTANYL, CLONIDINE, AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223377 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention