BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7956358 · Received October 11, 2018

    Report

    Report Number
    3004209178-2018-22793
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    October 9, 2018
    Report Date
    December 20, 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
    AU
    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

    INTERROGATION OF THE PUMP THE MEDTRONIC NEUROMODULATION RETURN PRODUCT ANALYSIS LAB INDICATED THE PUMP WAS DELIVERING VENDAL AND THE CATHETER MODEL WAS 8711. PRODUCT ID 8711, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8711, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN. ANALYSIS OF THE PUMP REVEALED CORROSION, WEAR, LUBRICATION, AND STALL DUE TO SHAFT-BEARING ANOMALIES OF THE PUMP MOTOR GEAR TRAIN. ANALYSIS OF THE CATHETER IDENTIFIED THE CATHETER BODY WAS BROKEN. DEVICE CODE (B)(4) PERTAINS TO THE CATHETER. CONCLUSION CODE PERTAINS TO THE PUMP; CONCLUSION CODE PERTAINS TO THE CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE 20 MG/ML AT 8,703 MG/DAY. THE INDICATION FOR USE WAS NOT REPORTED. IT WAS REPORTED A ¿MOTOR STOP¿ OCCURRED. THE PUMP AND CATHETER WERE REPLACED. THE ISSUE WAS RESOLVED. THE PATIENT'S STATUS WAS ALIVE - NO INJURY. DIAGNOSTICS/TROUBLESHOOTING INCLUDED ¿X-RAY.¿ NO INFORMATION WAS AVAILABLE REGARDING ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MIGHT HAVE LED OR CONTRIBUTED TO THE EVENT. THE PATIENT¿S AGE, WEIGHT, AND MEDICAL HISTORY WERE UNAVAILABLE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797368 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention