BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4141281 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18312
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 10, 2014
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A MOTOR GEAR TRAIN ANOMALY. THERE WAS CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHAFT BEARING.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    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 RECEIVED REPORTED THAT THE PATIENTS STATUS AFTER THE DEVICE WAS REMOVED WAS "RECOVERED WITHOUT SEQUELA." THERE WAS NO PATIENT INJURY. A ROTOR STUDY AND DYE STUDY WERE PERFORMED BUT NO RESULTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL AND RECOVERY RECORDED IN THE EVENT LOGS. THE PATIENT CONTACTED THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014 STATING THAT THE PUMP WAS ALARMING AND A MOTOR STALL ERROR CODE WAS SEEN ON THE PERSONAL THERAPY MANAGER (PTM). THE MOTOR STALL RECOVERED THE NEXT DAY. THE REPORTER DENIED ANY ELECTROMAGNETIC INTERFERENCE (EMI) OR MAGNETIC INTERACTION. THE PUMP WAS REFILLED AND INFUSING AT A THERAPEUTIC RATE. THE PATIENT DID EXPERIENCE INCREASED PAIN AND NAUSEA DURING THE MOTOR STALL. THE PATIENT WAS GIVEN ORAL PAIN MEDICATION DURING THAT TIME. THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT THE NEXT DAY, BUT THE REPORTER WAS UNSURE IF THAT WAS NECESSARY BECAUSE, THE STALL RECOVERED. FURTHER INFORMATION RECEIVED STATED THAT A MOTOR STALL RECURRED ON (B)(6) 2014 AND IT WAS UNKNOWN IF IT RECOVERED. THE PUMP WAS SUBSEQUENTLY REPLACED ON (B)(6) 2014. THE PATIENT¿S STATUS AT THE TIME OF THE EVENT WAS SAID TO BE ALIVE AND NO INJURY. THE PUMP WAS USED TO DELIVER CLONIDINE 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
    619803 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention