BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162215 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10130
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    December 14, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L79089, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALY. THE PUMP HAD REACHED EOS (END OF SERVICE) DUE TO TIME PROGRESSION. ANALYSIS OF THE RETURNED PORTION OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY/ACCEPTABLE CATHETER TESTING. CORRECTED INFORMATION: CONCLUSION CODE 54 NO LONGER APPLIES FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L79089, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. 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

    IT WAS REPORTED THAT THE INTRATHECAL DRUG INFUSION PUMP FAILED. THE PATIENT ALSO HAD GRANULOMAS. THE PUMP AND PART OF THE CATHETER WERE EXPLANTED. THERE WAS REPORTED TO BE NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. WHEN THE PUMP WAS REMOVED, PART OF THE CATHETER WAS LEFT IN BECAUSE THEY COULDN'T GET IT OUT. THE EVENT OCCURRED IN 2013 OR 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262772 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention