BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3843125 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09952
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 85 96SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WITHDRAWAL WITH SYMPTOMS OF AN ALTERED MENTAL STATE, AGITATION AND VERY SPASTIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 AT APPROXIMATELY 2200. THE PATIENT WAS INTUBATED. THE HOSPITAL PHYSICIAN KNEW NOTHING ABOUT THE PUMP OR HAD ANY OTHER DETAILS. IT WAS REPORTED THAT THE PUMP WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED BY THE HOSPITAL RESIDENT ON-CALL THAT THE PATIENT WAS GIVEN ANTIBIOTICS; THE REPORTER WOULD NOT PROVIDE THE REASON FOR ADMINISTERING THE ANTIBIOTICS STATING IT WAS PRIVATE. HE SAID THAT THE PATIENT PRESENTED WITH AN ALTERED MENTAL STATUS OF UNKNOWN ORIGIN. THE PATIENT HAD A HISTORY OF SIMILAR EPISODES NONE OF WHICH WERE DEVICE RELATED. THEY HAD NO CLEAR EXPLANATION FOR HIS CURRENT EPISODE. HE SAID THAT THE PUMP HAD NOT BEEN CHECKED BUT IT WAS NOT SUSPECTED AS CAUSING AN ISSUE. THE PATIENT TOOK ORAL BACLOFEN AND HAD A HISTORY OF TAKING TOO MUCH ORAL BACLOFEN. HE WAS SEEN BY NEUROSURGERY (B)(6) 2014 AND HAD NO FOCAL DEFICIT. THE PATIENT HAD A CHRONIC SUBDURAL HEMATOMA BUT NEUROSURGERY DID NOT THINK THAT WAS WHY HE WAS EXPERIENCING AN ALTERED MENTAL STATUS AT THIS TIME. HE WAS MOVED FROM THE ICU (INTENSIVE CARE UNIT) TO THE FLOOR A FEW DAYS AGO. THE RESIDENT FROM THE FLOOR THE PATIENT WAS CURRENTLY ON STATED THAT THE PUMP WAS INTERROGATED ON (B)(6) 2014. ON INTERROGATION, THE PUMP WAS FOUND TO BE DELIVERING DILAUDID AND IT WAS FUNCTIONING PROPERLY AND DELIVERING MEDICATION AS PROGRAMMED. NO ISSUES WERE NOTED. THE CATHETER HAD NOT BEEN EXAMINED. THE RESIDENT STATED THAT AT THIS POINT THEY DID NOT KNOW WHAT WAS CAUSING THE PATIENT¿S MENTAL STATUS BUT THAT IT HAD BEEN HARD TO MAKE A DETERMINATION BECAUSE THEY HAD GIVEN HIM SEVERAL IV (INTRAVENOUS) MEDICATIONS THAT WERE SEDATING. AT THIS POINT, THE PATIENT WAS BEING MONITORED. IT WAS NOTED THAT THEY WERE NO CLOSER TO FINDING A CAUSE FOR THE EVENT THAN WHEN HE WAS ADMITTED HOWEVER, THE PUMP WAS NOT BEING THOUGHT TO HAVE CAUSED THE ISSUE. IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN HAVING AN INTERMITTENT ALTERED MENTAL STATUS/"WAXES AND WANES" SINCE HIS ADMISSION TO THE HOSPITAL. THIS REPORTER STATED THAT THERE WAS A QUESTION AS TO THE DRUG IN THE PUMP. THIS HCP (HEALTH CARE PROVIDER) WAS TOLD BY THE PATIENT¿S FOLLOW-UP HCP THAT THE PUMP HAD DILAUDID IN IT, BUT THERE WAS ALSO SOME MENTION OF BACLOFEN. THIS HCP DID NOT BELIEVE THAT THERE WAS AN ISSUE WITH THE PUMP. IT WAS LATER REPORTED BY THE PATIENT¿S FOLLOW-UP HCP THAT THE PUMP WAS DELIVERING DILAUDID 30 MG/ML AT 8.79 MG/DAY SINCE 2007. THE CAUSE OF THE PATIENT¿S EVENT WAS UNKNOWN. THE PUMP WAS INTERROGATED AND WAS WORKING PROPERLY. IT WAS REPORTED TO BE AN ¿UNRELATED DIAGNOSIS¿. THE PATIENT WAS NOT RECOVERED AS OF (B)(6) 2014; THE SYMPTOMS/ISSUES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321855 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization