BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6039298 · Received October 19, 2016

    Report

    Report Number
    3004209178-2016-22046
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 3, 2016
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP IDENTIFIED CORROSION AND/OR WEAR AND/OR LUBRICATION OF THE GEAR TRAIN, AND A STALL DUE TO SHAFT BEARING. EVALUATION CONCLUSION CODE NO LONGER APPLIES. RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE BECAUSE, ALTHOUGH THE DEVICE MEETS DESIGN SPECIFICATION, MEDTRONIC MADE ENHANCEMENTS TO THE DESIGN MAKING THIS THE CLOSEST CODE AVAILABLE WITH RESPECT TO THIS EVENT.

    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 WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. THE PUMP WAS RETURNED ON (B)(6) 2016.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING LIORESAL (CONCENTRATION 500MCG/ML, DOSE 263.52 MCG/DAY) FOR INTRACTABLE SPASTICITY AND CEREBROVASCULAR (STROKE) DAS SYSTEM THE EVENT DATE WAS (B)(6) 2016. THE PUMP WAS EXPLANTED ON THIS REPORT DATE DUE TO PUMP ALARMS AS A RESULT OF MULTIPLE MOTOR STALLS/RECOVERY; THE STALLS WERE NOTED VIA PUMP INTERROGATION, LOGS WERE READ. PER THE EVENT LOGS AND PRINT REPORT PROVIDED, AN ACTIVE AUDIBLE ALARM WAS SILENCED ON (B)(6) 2016 18:02. A STALL RECOVERY WAS NOTED ON (B)(6) 2016 00:32, STALL OCCURRED (B)(6) 2016 10:28 WITH RECOVERY 12:53. STALLED OCCURRED (B)(6) 2016 01:29, RECOVERED 07:30, STALLED AGAIN 10:12, RECOVERED 12:27, STALLED AGAIN 15:09, RECOVERED 16:22, STALLED AGAIN 19:56, RECOVERED (B)(6) 2016 00:41, STALLED AGAIN 06:05. THE ESTIMATED ELECTIVE REPLACEMENT INDICATOR WAS 4M. THERE WERE NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THERE WERE NO PATIENT SYMPTOMS MENTIONED. AT THE TIME OF THIS REPORT, THE ISSUE WAS RESOLVED, PATIENT STATUS WAS "ALIVE - NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690564 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention