BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7481720 · Received May 2, 2018

    Report

    Report Number
    3007566237-2018-01324
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 29, 2018
    Report Date
    June 13, 2018
    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
    IZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE SERIAL NUMBER OF THE PUMP WAS PROVIDED. THE PUMP WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THE MOTOR STALL OCCURRED AND STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGES OCCURRED. WHEN ASKED IF ONLY ONE MOTOR STALL OCCURRED, IT WAS STATED, "YES WITH PEEP , RECOVERED AND RETURNED BACK TO PEEP." THE ACTION TAKEN WAS TO CONVERT IT FROM SIMPLE CONTINUOUS TO STOPPED PUMP STATUS, THEN RETURN IT BACK AGAIN TO SIMPLE CONTINUOUS. WHEN ASKED TO PROVIDE THE PUMP EXPLANT DATE AND RETURN STATUS IF THE PUMP WAS TO BE EXPLANTED, THE REPRESENTATIVE STATED, "FOR THE REST OF QUESTIONS THEY ARE NOTHING TILL NOW TO DECIDE TO RE-IMPLANT NEW ONE."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE REPRESENTATIVE STATED THEY DID NOT HAVE THE ABILITY TO EXPLANT THE PUMP BECAUSE THE PATIENT DIDN'T LIKE TO RETURN BACK TO (B)(6). THE PATIENT HAD VISITED THE HOSPITAL IN (B)(6), AND THE PROGRAMMING GUY HAD SENT THE ERROR (MOTOR STALL). WHEN ASKED IF THE PUMP WAS IMPLANTED AFTER THE USE BEFORE DATE, THE RESPONSE WAS, "THE PUMP IS IMPLANTED UNDER THE HOSPITAL RESPONSIBILITIES IT WAS (B)(6) HOSPITAL." A PUMP PRINTOUT FROM AN INTERROGATION ON (B)(6) 2018 AT 10:56 WAS PROVIDED. THE PUMP WAS IN A STATE OF MOTOR STALL AND TUBE SET. THE ESTIMATED ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 56 MONTHS. PUMP LOGS WERE NOT READ.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING MORPHINE (10 MG/ML AT 3.5 MG/DAY) VIA AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED MOTOR STALL OCCURRED. THE EVENT DATE WAS STATED TO BE (B)(6) 2018. THE PATIENT SUFFERED FROM PAIN. CONTRIBUTING FACTORS TO THE EVENT INCLUDED "THE PUMP NOT PUSHING DRUG INTO THE CATHETER." NO INTERVENTIONS WERE TAKEN; SURGICAL INTERVENTION DID NOT OCCUR AND WAS NOT PLANNED. IT WAS ALSO REPORTED THE PUMP REMAINED IMPLANTED AND IN SERVICE. THE ISSUE WAS NOT RESOLVED. THE PATIENT STATUS WAS ALIVE - NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321491 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR