BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6216670 · Received December 30, 2016

    Report

    Report Number
    3004209178-2016-27479
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    January 9, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND OVERINFUSION WITH AN UNDETERMINED ROOT CAUSE. THE PUMP WAS FOUND TO BE OVERINFUSING BY MORE THAN 14.5% AT STANDARD TEST CONDITIONS AND TYPICAL THERAPEUTIC RATE (300 UL/DAY). 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

    INTERROGATION OF THE PUMP DETERMINED IT WAS USED TO INFUSE DILAUDID 13.4 MG/ML AT 7.999 MG/DAY AND COMPOUNDED BACLOFEN 1676.0 MCG/ML AT 1000.5 MCG/DAY.

    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

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED BY A HEALTHCARE PROVIDER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING AN IMPLANTABLE INTRATHECAL PUMP INTENDED TO DELIVER AN UNKNOWN DRUG, INDICATED FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. THE PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS WITH NO KNOWN COMPLAINTS. THE ¿REASON FOR REMOVAL¿ WAS NOT PROVIDED ON THE RETURNED PRODUCT FORM. IT WAS INDICATED THAT NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866067 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1