BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6874327 · Received September 18, 2017

    Report

    Report Number
    3004209178-2017-19571
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Report Date
    October 19, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8780 LOT# (B)(4) IMPLANTED: (B)(6)2017EXPLANTED: PRODUCT TYPE CATHETER UPDATED MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THERE WAS A PATIENT THERAPY ISSUE WITH THE CATHETER DISCONNECTION. THE PATIENT WANTED THE PUMP OFF, AND THEY HAD TO RESCHEDULE THE SURGERY DUE TO THE PATIENT¿S RESPIRATORY ISSUES.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS RECEIVING MORPHINE (25 MG/ML CONCENTRATION AND 3 MG/DAY DOSE) VIA INTRATHECAL DRUG DELIVERY PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT AN ALARM FOR EMPTY PUMP WAS OCCURRING, THE HCP HAD AN ACCESS TO THE PHYSICIAN PROGRAMMER. THE PATIENT HAD MISSED THE REFILL. THE HCP RECENTLY MOVED FROM A DIFFERENT STATE AND THE PATIENT WAS NEW TO THE HCP. THE HCP STATED THAT THE EMPTY RESERVOIR OCCURRED IN THE BEGINNING OF (B)(6) ALONG WITH THE PATIENT HAVING WITHDRAWAL. THE HCP AND THE PATIENT WANTED TO PROGRAM THE PUMP TO OFF STATE NOW AND NOT FILL THE PUMP. THE HCP LATER REPORTED THAT THEY SENT BACK THE PUMP OFF AUTHORIZATION FORM AND WOULD LIKE TO CODE TO SHUT OFF THE PUMP. TECHNICAL SERVICE SPECIALIST (TSS) REVIEWED THE CODE FOR PUMP OFF. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS RESTARTED ON ORAL NARCOTICS AND THE WITHDRAWAL SYMPTOMS HAD RESOLVED. HEALTHCARE PROFESSIONAL (HCP) NOTED THAT THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS (B)(6)KG. HE STATED THAT X-RAYS WERE TAKEN AND THERE WAS SOME QUESTION ABOUT WHETHER THE CATHETER HAD BECOME DISCONNECTED, BUT THE PATIENT DECLINED A DYE STUDY OR REVISION SO IT COULD NOT BE CONFIRMED IF THE CATHETER WAS DISCONNECTED. HE STATED THAT HE FIGURED HE WOULD KNOW FOR SURE [IF THE CATHETER WAS DISCONNECTED] WHEN THE PUMP WAS REMOVED. THE HCP NOTED THAT THE PUMP WAS SCHEDULED TO BE REMOVED ON (B)(6)2017. THE HCP DID NOT KNOW IF THE PUMP WOULD BE RETURNED, BUT NOTED THAT HE WOULD ASK THE PATIENT WHEN THE PUMP WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653674 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR