BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2972671 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02956
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TELEMETRY CONFIRMED AN ALARM OCCURRED DUE TO ZERO MILLILITERS (ML) RESERVOIR VOLUME REACHED IN THE PUMP. IT WAS REPORTED THE PATIENT HAD BEEN AWAY FROM HOME WHEN HIS PUMP STARTED TO ALARM. THE PATIENT EXPERIENCED INCREASED PAIN. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM "LAST NIGHT" AND WAS ADMITTED TO THE HOSPITAL. UPON PUMP INTERROGATION, A LOW RESERVOIR AND EMPTY RESERVOIR MESSAGED WERE NOTED. ACCORDING THE PUMP LOGS, THE LAST CHANGE DATE WAS ON (B)(6) 2011 AND THE VOLUME DISPENSED BY THE PUMP WAS 111 ML'S. IT WAS REPORTED THE PATIENT HAD INDICATED HE HAD BEEN REFILLED "FIVE WEEKS AGO." THE DEVICE SYSTEM HAD BEEN USED TO ADMINISTER HYDROMORPHONE, CLONIDINE, AND BUPIVACAINE. IT WAS LATER REPORTED THAT ON (B)(6) 2013, THE ER REQUESTED THE PUMP BE INTERROGATED ON A DETAINED PATIENT. THE PATIENT WAS IN CUSTODY OF THE POLICE DEPARTMENT ON A WARRANT AND HAD CLAIMED HIS PUMP STARTED TO ALARM THAT MORNING AND NEEDED TO VISIT AN ER TO HAVE IT REFILLED. IT WAS REPORTED THE PATIENT HAD CLAIMED HE HAD RECENTLY HAD HIS PUMP REFILLED AT THE ER, HOWEVER, IT WAS REPORTED PER THE PUMP LOGS THE LAST CHANGE TO THE PUMP WAS (B)(6) 2011. PER THE LOGS, A LOW RESERVOIR DATE OF (B)(6) 2013 WAS NOTED ALONG WITH A LOW RESERVOIR ON (B)(6) 2011 AND AN EMPTY RESERVOIR MESSAGE ON (B)(6) 2011. IT WAS REPORTED THE PUMP WAS READ AND WAS WORKING PROPERLY. IT WAS REPORTED "NOBODY MANAGING THIS PUMP BASED ON PATIENT NONCOMPLIANCE." THE PATIENT EXPERIENCED NO INJURY, SYMPTOMS, OR ADVERSE EVENTS RELATED TO THE EVENT. IT WAS LATER REPORTED THE PATIENT'S HEALTH CARE PROVIDER, WHO WAS ON CALL, DECIDED NOT TO CONTINUE TO MANAGE THE PATIENT'S MEDICATIONS THROUGH THE PUMP. PER PUMP LOGS, A LOW RESERVOIR ALARM HAD OCCURRED ON (B)(6) 2013. 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
    77423 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization