BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA INTRATHECAL CATHETER

    MDR report key: 6094370 · Received November 10, 2016

    Report

    Report Number
    3006803715-2016-00177
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 14, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A CATHETER WAS NOT EXPLANTED DURING THE (B)(6) 2016 SURGERY. THE ISSUE WAS RESOLVED BY CONNECTING A CATHETER REVISION KIT WITH THE REST OF THE EXISTING IMPLANTED CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS, WHICH INCLUDED SPASMS AND ITCHING, DURING THE WEEK BEFORE AND LEADING UP TO (B)(6) 2016. DURING ASPIRATION OF THE PUMP, MEDICATION WAS OBSERVED EXITING THE SKIN AT THE WOUND SITE WHERE THE NEEDLE WAS INSERTED PREVIOUSLY, AND SOME SWELLING AROUND THE POCKET SITE WAS NOTED. A VALVE ACTUATION TEST WAS PERFORMED, AND IT WAS DETERMINED THAT THE PUMP WAS FUNCTIONING NORMALLY. A REVISION SURGERY TOOK PLACE ON (B)(6) 2016. THE CATHETER WAS FOUND TO HAVE TEARS, WHICH MAY BE RELATED TO THE WITHDRAWAL SYMPTOMS. A CATHETER REVISION KIT WAS USED TO RESOLVE THE ISSUE. THE PHYSICIAN BELIEVES THAT THE CATHETER TEARS WERE DUE TO ABDOMINAL GROWTH FROM THE PATIENT'S PREGNANCY. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743876 PROMETRA INTRATHECAL CATHETER IMPLANTABLE INTRATHECAL CATHETER LKK FLOWONIX MEDICAL, INC 91823 18895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other