BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5016360 · Received August 19, 2015

    Report

    Report Number
    3004209178-2015-16332
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    July 27, 2015
    Report Date
    November 17, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP ((B)(4)) MOTOR GEAR TRAIN ANOMALY, CORROSION AND OR WEAR AND OR LUBRICATION, STALL DUE TO SHAFT-BEARING. ADDITIONAL REVIEW DETERMINED THAT THE CONCLUSION CODE NO LONGER APPLIES AND HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N191753, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4). ADDITIONAL INFORMATION WAS REPORTED BY THE COMPANY REPRESENTATIVE, THE PUMP WAS REPLACED ON (B)(6) 2015.

    Description of Event or Problem · 1

    AFTER THE PUMP ALARM HAD BEEN SILENCED, THE PUMP STARTED ALARMING AGAIN A FEW DAYS LATER. IT WAS CONFIRMED THAT INTERROGATION SHOWED A "MOTOR STALL OCCURRED" MESSAGE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE WITH THE RETURNED PRODUCT REGARDING A (B)(6) YEAR OLD FEMALE PATIENT RECEIVING INTRATHECAL SODIUM CHLORIDE 1.0MG/ML VIA AN IMPLANTABLE INFUSION PUMP. THE LOGS THAT WERE RETURNED WITH THE DEVICE INDICATED DUPLICATE MOTOR STALLS, TUBE SET MESSAGES, RECOVERIES, PUMP STOPPED DUE TO OFF STATE (1092:15 H:M) IN A SESSION DATA REPORT WHERE THE YEAR FOR ALL THE EVENTS WAS DOCUMENTED AS 2039. THE DEVICE WAS RETURNED. THE SERIAL NUMBER FOR THE 8840 THAT HAD BEEN USED TO PUT THIS PUMP INTO STOPPED PUMP MODE REMAINED UNKNOWN AT THE TIME OF THIS EVENT. FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN THE MISSING INFORMATION; IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN ELECTROCARDIOGRAM ON (B)(6) 2015. ON (B)(6) 2015, A HEALTHCARE PROVIDER (HCP) REPORTED A PUMP MOTOR STALL, WHICH WAS REVEALED AT AN INITIAL INTERROGATION OF THE PUMP, AND A STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE WAS REPORTED. THERE WAS ALSO A REPORT THAT THE PUMP HAD BEEN STALLING INTERMITTENTLY. THE PATIENT DID NOT HAVE AN MRI. THE PATIENT EXPERIENCED A SUDDEN CHANGE IN THERAPY, AND EXHIBITED THE FOLLOWING SIGNS AND SYMPTOMS: WITHDRAWAL, SHAKING, SWEATING, VOMITING, DIZZINESS, FEELING HOT AND COLD, AND INCREASED PAIN. THE PATIENT HAD BEEN RECEIVING INTRATHECAL MORPHINE 10 MG/ML AT 5.552 MG/DAY. THE PUMP WAS FILLED WITH SALINE AND PROGRAMMED TO MINIMUM RATE. THE HCP LATER REPORTED ON (B)(6) 2015 THAT THE PATIENT WAS NOT FEELING WELL, AND THEY HAD BEEN MANAGING THEIR WITHDRAWALS SINCE THE MOTOR STALL OCCURRED. THE PUMP ALARM HAD BEEN SILENCED AFTER THE MOTOR STALL EVENT, AND THEN THE PUMP STARTED ALARMING AGAIN A FEW DAYS LATER. THE PUMP OFF PASSWORD WAS PROVIDED, AND THE HCP PLANNED TO REPLACE THE PUMP. THE CAUSE OF THE MOTOR STALL WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE CAUSE OF THE MOTOR STALL AS WELL AS IF THE STALL AND WITHDRAWAL SYMPTOMS HAD RESOLVED. THE PATIENT WAS INDICATED FOR THE FOLLOWING USES: NON-MALIGNANT PAIN AND OTHER CHRONIC, INTRACTABLE PAIN OF THE TRUNK/LIMBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546804 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention