BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3872185 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01638
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 870953, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE ALSO NOTE THAT MANUFACTURER REPORT # 3007566237-2015-01017 WAS PREVIOUSLY SUBMITTED WITH A DATE OF 2014-05-27, BUT THIS DUPLICATE EVENT WAS IDENTIFIED AND THEREFORE MANUFACTURER REPORT # 3007566237-2015-01017 SHOULD NOT HAVE BEEN SUBMITTED LATE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CATHETER WAS STILL IMPLANTED AS IT WAS BROKEN INTO THE INTRATHECAL SPACE. THE PHYSICIANS HAD DECIDED TO DO A CHECK AND LATER REMOVE THE CATHETER. CURRENTLY, THE PATIENT WAS NOT RECEIVING A 100% EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    THE FOLLOWING DUPLICATE INFORMATION WAS PREVIOUSLY CAPTURED IN MANUFACTURER REPORT #3007566237-2015-01017: IT WAS REPORTED THE PATIENT'S CATHETER WAS BROKEN. THE HEALTHCARE PROFESSIONAL (HCP) IDENTIFIED THIS WEEK THAT A BIG RESIDUAL FRAGMENT OF THE CATHETER WAS "UNLEASHED" IN THE INTRATHECAL SPACE. THERE WERE NO PATIENT SYMPTOMS REPORTED, THE OUTCOME OF THE EVENT WAS UNKNOWN AND THE MEDICATION USED IN THE PUMP WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. NOW, FURTHER NEW INFORMATION SUGGESTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THIS WAS CONFLICTING INFORMATION TO WHAT WAS RECEIVED IN JULY 2014. THEREFORE, ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE FINAL RESOLUTION, THE STATUS OF THE CATHETER, AND THE CURRENT PATIENT STATUS. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER BREAK OCCURRED AT THE CATHETER TIP. A SEGMENT OF THE CATHETER INTO THE INTRATHECAL SPACE AND IS HARD TO REMOVE. THIS REQUIRED A REVISION AND DURING THE REVISION TRACKING OF THE POSITION OF THE CATHETER SEGMENT. THE X-RAYS WERE PERFORMED. THE ISSUE WAS REPORTED AS NOT RESOLVED AND UNKNOWN AS TO THE CAUSE OF THIS ISSUE. THE PRODUCT WAS REPORTED TO BE IMPLANTED AND REMAINING IN-SERVICE. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. IT WAS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SYMPTOMS ASSOCIATED WITH THIS EVENT. THIS DEVICE SYSTEM DELIVERED MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349738 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention