BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6555772 · Received May 9, 2017

    Report

    Report Number
    3004209178-2017-09966
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    May 3, 2017
    Report Date
    July 3, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE FOUND THAT THE PUMP WAS DELIVERING 25 MG/ML MORPHINE AT 0.154 MG/DAY. ANALYSIS OF THE PUMP FOUND THAT THERE WAS HIGH RESISTANCE IN THE PUMP BATTERY. EVAL CODE-CONCLUSION UPDATED. 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

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A CONSUMER RECEIVING AN UNKNOWN DRUG AT AN UNKNOWN CONCENTRATION AND DOSAGE VIA INTRATHECAL DRUG DELIVER PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT HAD THEIR REFILL ABOUT A MONTH AGO AND AT THAT POINT IT SHOWED THAT THE PATIENT STILL HAD 13 MONTHS UNTIL THEIR ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT CAME IN ON (B)(6) 2017 FOR A REFILL AND IT IS SHOWING THAT ERI HAS ALREADY OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE PREMATURE ERI. THE LOGS WERE CHECKED AND THE PATIENT WAS TO BE SCHEDULED FOR A PUMP REPLACEMENT. THE ISSUE WAS CONSIDERED UNRESOLVED AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335764 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention