BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6928132 · Received October 9, 2017

    Report

    Report Number
    3004209178-2017-21316
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    October 4, 2017
    Report Date
    February 13, 2018
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    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

    ANALYSIS OF THE IMPLANTABLE PUMP MOTOR (SERIAL # (B)(4)) IDENTIFIED CORROSION ON GEAR WHEEL NUMBER THREE AND RESIDUE ON THE GEAR SHAFT OF THE MOTOR GEAR TRAIN THAT RESULTED IN THE MOTOR STALLS. F INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION/UPDATE: DEVICE CODE (B)(4). 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING COMPOUNDED BACLOFEN 145MCG/ML; 65.2 MCG/DAY AND DILAUDID 14 MG/ML; 6.3 MG/DAY VIA AN IMPLANTABLE PUMP. INDICATION FOR USE WAS NON MALIGNANT PAIN. THE DATE OF THE EVENT WAS (B)(6) 2017. IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FEELING UNWELL. THE REPRESENTATIVE WAS CALLED IN TO INTERROGATE THE PUMP. THE PUMP WAS INTERROGATED PUMP AND IT WAS DETERMINED THAT THE PUMP HAD UNDERGONE MULTIPLE MOTOR STALLS AND RECOVERIES BEGINNING ON (B)(6) 2017. MOTOR STALL OCCURRED (B)(6) 2017 14:15; STOPPED PUMP PERIOD MAY EXCEED TUBE SET (B)(6) 2017 14:15; MOTOR STALL RECOVERY OCCURRED (B)(6) 2017 21:18; MOTOR STALL OCCURRED (B)(6) 2017 22:36 ; MOTOR STALL RECOVERY OCCURRED (B)(6) 2017 05:03; MOTOR STALL OCCURRED (B)(6) 2017 13:47; MOTOR STALL RECOVERY OCCURRED (B)(6) 2017 16:30; MOTOR STALL OCCURRED (B)(6) 2017 17:36; STOPPED PUMP PERIOD MAY EXCEED TUBE SET (B)(6) 2017 17:36' MOTOR STALL RECOVERY OCCURRED (B)(6) 2017 02:13; MOTOR STALL OCCURRED (B)(6) 2017 22:53; MOTOR STALL RECOVERY OCCURRED (B)(6) 2017 04:20; MOTOR STALL OCCURRED (B)(6) 2017 06:38; STOPPED PUMP PERIOD MAY EXCEED TUBE SET (B)(6) 2017 06:38; STATE MOTOR STALL RECOVERY OCCURRED (B)(6) 2017 13:45. THE DOSE WAS REDUCED TO MEDICALLY MANAGE BASED ON DOCTOR'S ORDERS. IT WAS UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP WAS STILL IMPLANTED. IT WAS UNKNOWN IF SURGICAL INTERVENTION WAS PLANNED. PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE - NO INJURY. THE ISSUE WAS NOT RESOLVED. PATIENT WEIGHT AND MEDICAL HISTORY WAS ASKED AND WILL NOT BE MADE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). AFTER THE MOTOR STALL RECOVERY OCCURRED THE FLOW RATED WAS REDUCED. WHEN THE MOTOR STALLS CONTINUED TO OCCUR, THE PUMP WAS SET TO MINIMUM FLOW RATE. THE PATIENT WAS PLACED ON ORAL MEDICATION TO TREAT THEIR PAIN AND WITHDRAWAL SYMPTOMS. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2017 TO REPLACE THE PUMP. THE MOTOR STALL AND PATIENT FEELING UNWELL HAS NOT BEEN RESOLVED. (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) ON 2017-DEC-22. THE PUMP WAS RETURNED TO THE MANUFA CTURER FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE. IT WAS UNKNOWN WHAT ACTIONS WERE TAKEN. IT WAS UNKNOWN IF THE MOTOR STALLS AND PATIENT FEELING UNWELL WERE RESOLVED. THE DEVICE WAS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711871 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention