BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6584580 · Received May 23, 2017

    Report

    Report Number
    3004209178-2017-10848
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    December 29, 2016
    Report Date
    July 28, 2017
    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

    ANALYSIS IDENTIFIED CORROSION AND/OR WEAR AND/OR LUBRICATION ISSUES OF THE GEAR TRAIN. ANALYSIS IDENTIFIED STALL DUE TO SHAFT-BEARING. EVAL CODE-RESULT UPDATED TO 180, 925. EVAL CODE-CONCLUSION UPDATED TO 24. 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 RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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 RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2017-JUNE-06, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP). IT WAS ASKED IF THE MOTOR STALL RECOVERED, THE REP REPORTED, "NOW". IT WAS ASKED WHEN THE MOTOR STALL OCCURRED, THE REP ANSWERED, "DURING USER". IT WAS ASKED HOW THE MOTOR STALL WAS IDENTIFIED, THE REP REPORTED, "UNKNOWN, ALARM, UNDERDOES?" IT WAS "UNKNOWN" IF THERE WERE SYMPTOMS RELATED TO THE MOTOR STALL. THE PUMP WAS REPLACED WITH ANOTHER PUMP (SAME MANUFACTURER, UNKNOWN SERIAL NUMBER).

    Description of Event or Problem · 1

    ON 2017-JUNE-06, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP). IT WAS ASKED IF THE MOTOR STALL RECOVERED, THE REP REPORTED, "NOW". IT WAS ASKED WHEN THE MOTOR STALL OCCURRED, THE REP ANSWERED, "DURING USER". IT WAS ASKED HOW THE MOTOR STALL WAS IDENTIFIED, THE REP REPORTED, "UNKNOWN, ALARM, UNDERDOES?" IT WAS "UNKNOWN" IF THERE WERE SYMPTOMS RELATED TO THE MOTOR STALL. THE PUMP WAS REPLACED WITH ANOTHER PUMP (SAME MANUFACTURER, UNKNOWN SERIAL NUMBER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367239 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention