BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5993297 · Received October 3, 2016

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    3004209178-2016-20212
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 12, 2016
    Report Date
    November 30, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED INFORMATION (PUMP HAD NOT BEEN WORKING FOR A LONG TIME) PERTAINS TO MANUFACTURER REPORT # 3004209178-2016-20222. INFORMATION REGARDING THAT EVENT WILL BE SENT IN THAT MANUFACTURER REPORT.

    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

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THERE WAS ADDITIONAL INFORMATION REPORTED THAT WAS NOT RELEVANT TO THIS EVENT AND THEREFORE WAS OMITTED; SEE PE 701473032-VOLUME DISCREPANCY, KINKED CATHETER; REVISION. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2016 FROM A HEALTHCARE PROFESSIONAL (HCP) STATED THE MAGNETIC RESONANCE IMAGING (MRI), X-RAYS, AND COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE CATHETER TO BE IN PLACE. IT WAS UNKNOWN IF THE PAIN WAS RESOLVED OR HOW IT WAS RESOLVED. NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE. THE MANUFACTURER REPRESENTATIVE DID NOT KNOW THE EXACT DATE NOR DID THEY KNOW IF AN ACTUAL HOSPITALIZATION OCCURRED. THE REPRESENTATIVE BECAME AWARE OF THE EVEN ON (B)(6) 2016.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING BUPIVACAINE AND MORPHINE AT UNKNOWN CONCENTRATIONS AND DOSAGES VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS HAVING AN MRI DUE TO A PROBLEM WITH THE DEVICE OR THERAPY. THE PATIENT WAS HAVING PAIN. THIS WAS CONSIDERED A SUDDEN CHANGE IN THERAPY. THE HCP REPORTED THAT THE PATIENT SAID THE PUMP HAD NOT BEEN WORKING FOR A LONG TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED BY A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT IN (B)(6) 2016, THE PATIENT HAD TO SPEND A FEW NIGHTS IN THE INTENSIVE CARE UNIT. THE EXACT DATES SHE WAS THERE WERE UNKNOWN. THE PATIENT'S HOSPITAL STAY WAS DUE TO HER BEING IN UNCONTROLLED PAIN AND DID NOT HAVE A PERSONAL THERAPY MANAGER. THE PATIENT'S DOCTOR HADN'T PROGRAMMED THE PERSONAL THERAPY MANAGER YET. THE PATIENT REPORTED THAT THE DOCTOR'S OFFICE REACHED OUT TO THE MANUFACTURER BUT NO ONE CAME. IT WAS NOTED THAT A MANUFACTURER REPRESENTATIVE SAW THE PATIENT AT THE HOSPITAL A FEW WEEKS AFTER THE PUMP WAS IMPLANTED, WHICH OCCURRED ON (B)(6) 2016. THE MANUFACTURER REPRESENTATIVE WAS GOING TO SEE THE PATIENT AGAIN ON (B)(6)2016, BUT THE PATIENT DID NOT SHOW UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT WENT THROUGH COMPLETE WITHDRAWAL AND NOBODY FROM THE MANUFACTURER CAME TO CHECK ON HER PUMP. IT WAS REPORTED THAT THEY ASPIRATED THE DRUG OUT OF THE PATIENT'S PUMP AND FOUND THERE WAS NO CHANGE IN THE AMOUNT, AND THE PUMP WAS NOT ALARMING. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR 3 WEEKS AND WHILE SHE WAS THERE SHE WENT INTO ATRIAL FIBRILLATION AND ENDED UP IN THE CARDIAC INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT THE NEW PUMP THAT WAS MOST RECENTLY IMPLANTED, (B)(4), WAS WORKING FINE AT THE TIME OF THIS REPORT BUT HER HEART WAS NOT, AND SHE WAS UPSET THAT SHE HAD NOT BEEN CONTACTED FROM THE MANUFACTURER NOR DID ANYONE CHECK THE PUMP TO DETERMINE IF SOMETHING WAS WRONG; THE HEALTHCARE PROVIDER (HCP) CALLED THE MANUFACTURER 2-3 TIMES AND EACH TIME THE MANUFACTURER SAID THE PUMP WAS WORKING. IT WAS REPORTED THAT THE SITUATION WAS BEING ADDRESSED BY THE HCP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645981 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L