BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6341374 · Received February 17, 2017

    Report

    Report Number
    3007566237-2017-00720
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    June 18, 2015
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N213449, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN HAVING SYMPTOMS OF SEDATION AND A CHANGE IN MENTAL STATUS THAT HAD STARTED ABOUT A WEEK PRIOR TO (B)(6) 2015. THE PATIENT¿S PUMP MANAGING PHYSICIAN HAD BEEN CONTACTED. THE PATIENT WAS CURRENTLY AT ANOTHER MEDICAL CENTER AND THE PHYSICIAN THERE WANTED THE PUMP INTERROGATED. THE DEVICE SYSTEM WAS DELIVERING FENTANYL AND BUPIVACAINE. THE INTERVENTIONS AND CAUSE OF THE SYMPTOMS WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). IT WAS UNKNOWN WHAT DIAGNOSTICS WERE PERFORMED RELATED TO THE SEDATION AND CHANGE IN MENTAL STATUS. THE TOTAL DAILY DOSE (TDD) WAS DECREASED BY 10% TO RESOLVE THE SEDATION AND CHANGE IN MENTAL STATUS. THE CAUSE OF THE SYMPTOMS WERE NOT DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY. THE PATIENT WAS RECEIVING FENTANYL (3,000.0 MCG/ML AT 1,048.1 MCG/DAY) AND BUPIVACAINE (5.0 MG/ML AT 1.7469 MG/DAY) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN, FAILED BACK SURGERY SYNDROME, AND POST LUMBAR LAMINECTOMY SYNDROME. ON (B)(6) 2015, THE PATIENT WAS SEEN IN THE HOSPITAL. THE PATIENT WAS ¿MONITORED IN HOSPITAL OUT OF AREA¿ ON (B)(6) 2015. THE PATIENT¿S CARE WAS TO BE TRANSFERRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OVERSEDATION. THE EVENT REQUIRED IN-PATIENT OR PROLONGED HOSPITALIZATION. THE CLINICAL DIAGNOSIS WAS ¿PATIENT WAS ADMITTED TO HOSPITAL FOR OVERSEDATION.¿ THE EVENT RESULTED IN AN EMERGENCY ROOM VISIT. THE EVENT WAS POSSIBLY RELATED TO THE DEVICE/THERAPY. THE EVENT WAS NOT RELATED TO THE IMPLANT PROCEDURE. THE EVENT WAS POSSIBLY RELATED TO THE DRUG (FENTANYL/BUPIVACAINE). THERE WAS NO CHANGE IN THE DRUG THAT CAUSED THE EVENT. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123598 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization