BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5932514 · Received September 7, 2016

    Report

    Report Number
    3004209178-2016-18369
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    July 10, 2016
    Report Date
    October 5, 2016
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE 12 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

    ANALYSIS OF THE PUMP REVEALED CORROSION ON GEAR WHEEL THREE, AND SHAFT WEAR ON THE UPPER SHAFT OF GEAR TWO. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A DEVICE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING 10 MG/ML MORPHINE AT 20.991 MG/DAY VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT THERE WERE SEVERAL MOTOR STALLS AND RECOVERIES BETWEEN THE DATES OF (B)(6) 2016. THE PATIENT HAD NOT RECENTLY HAD AN MRI. IT WAS NOTED THAT THE PATIENT HAD WITHDRAWAL SYMPTOMS ON (B)(6) 2016, WHICH WAS CONSIDERED A SUDDEN CHANGE IN SYMPTOMS. THE CAUSE OF THE MOTOR STALLS WAS NOT DETERMINED. THE PUMP WAS REPLACED ON (B)(6) 2016. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 11:50, WITH A RECOVERY ON (B)(6) 2016 AT 09:23. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 18:29, WITH A RECOVERY ON (B)(6) 2016 AT 06:00. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 21:10, WITH A RECOVERY ON (B)(6) 2016 AT 07:23. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 14:41 WITH A RECOVERY ON (B)(6) 2016 AT 18:20. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 20:44 WITH A RECOVERY ON (B)(6) 2016 AT 10:45. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 13:13 WITH A RECOVERY ON (B)(6) 2016 AT 09:44. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 18:08 WITH A RECOVERY ON (B)(6) 2016 AT 03:07. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 08:01 WITH A RECOVERY ON (B)(6) 2016 AT 19:12. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 00:40 WITH A RECOVERY ON (B)(6) 2016 AT 16:47. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 21:39 WITH A RECOVERY ON (B)(6) 2016 AT 14:00. ON (B)(6) 2016, A MOTOR STALL OCCURRED AT 08:42 WITH A RECOVERY ON (B)(6) 2016 AT 18:39.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584212 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention