BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4950744 · Received July 29, 2015

    Report

    Report Number
    3004209178-2015-14312
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALIES. THESE INCLUDED CORROSION AND/OR WEAR AND/OR LUBRICATION AND STALL DUE TO SHAFT-BEARING. THE DEVICE SYSTEM DELIVERED BACLOFEN IN A FLEX PATTERN WITH A CONCENTRATION OF 1000 G/ML, BASAL RATE 2.0 G/HR, AND A DAILY DOSE OF 605.3 G/DAY.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CRITICAL ALARM WAS NOTED ON (B)(6) AND THE PATIENT FELT A HEAVINESS, BACK SPASMS, AND SPASTICITY. THE PATIENT CAME TO THE HOSPITAL ON (B)(6) AND THE PHYSICIAN NOTED A MOTOR STALL. THE PUMP WAS INTERROGATED ON (B)(6) AND A MOTOR STALL WAS NOTED TO HAVE OCCURRED ON (B)(6) AT 18:28. THE PUMP WAS REPLACED ON (B)(6). THE ISSUE WAS REPORTED AS RESOLVED AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED LIORESAL. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493886 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention