BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4122772 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17827
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 2, 2014
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N233817, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD ON (B)(6) 2014 AND ALSO CONFIRMED BY TELEMETRY PER THE PATIENT'S PHYSICIAN. CONFLICTING INFORMATION REPORTED BY THE PATIENT, THAT THE ALARM WAS HEARD ON (B)(6) 2014, WHILE THE PATIENT WAS IN THE HOSPITAL FOR HIPS SURGERY UNRELATED TO THE PUMP SYSTEM. THE PATIENT HAD THEIR HIP IMPLANT REMOVED AND REPLACED BECAUSE THE PATIENT HAD COBALT IN THEIR BLOOD ON (B)(6) 2014. THE PATIENT REPORTED HEARING THREE BEEPS AT FIRST AND THEN IT CHANGED TO A DUAL TONE ALARM. TELEMETRY CONFIRMED A CRITICAL ALARM OCCURRING DUE TO MOTOR STALL. THE STALL WAS "CONSTANT." LOGS WERE PULLED AND THE MOTOR STALL OCCURRED ON (B)(6) 2014 AND TUBE SET ERROR OCCURRED ON (B)(6) 2014. PATIENT HAD NOT HAD AN MRI. THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS AND INCREASED PAIN. IT WAS ALSO REPORTED THAT ON (B)(6) 2014 (SUNDAY MORNING) THE PATIENT'S LEG WENT OUT WHEN THEY WERE WALKING WITH A WALKER. THE PATIENT STATED THAT EVERY NOW AND THEN THEY FEEL RADIATING PAIN AND THEN NUMBNESS. THE PATIENT WAS ADVISED TO GO INTO THE "ER BUT WAS SENT HOME." THE PATIENT REPORTED THAT THEY DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR MANUFACTURE REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT ALSO REPORTED THEY WERE STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT ARE WORKING WITH THEIR PHYSICIAN OR MANUFACTURE REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 AND ALSO HAD ONE SCHEDULED FOR (B)(6) 2014. IT WAS REPORTED THAT THE DEVICE WAS REMOVED. THE PUMP SYSTEM WAS DELIVERING CLONIDINE, ROPIVACAINE AND MORPHINE. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601057 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention