BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3844740 · Received June 3, 2014

    Report

    Report Number
    3007566237-2014-01504
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    January 30, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED NO SEGMENTS WERE LEFT IN THE INTRATHECAL SPACE. THE PATIENT POST-REVISION WAS INDICATED AS 섏ING WELL�

    Description of Event or Problem · 1

    INCREASED RESIDUAL VOLUME AT REFILLS WAS REPORTED. THE EXPECTED VOLUME WAS 7.6ML AND THE ACTUAL WAS 12.4ML. ON (B)(6) THE EXPECTED WAS 3.2 AND 10.2 ASPIRATED, ON (B)(6) THE EXPECTED 2.9 AND ASPIRATED 8.6. A DYE STUDY WAS SCHEDULED FOR THE DAY OF THE REPORT. THE PATIENT EXPERIENCED INCREASED PAIN BUT NO OTHER SYMPTOMS REPORTED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS INDICATED AS ALIVE NO INJURY. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION LATER REPORTED THE RESULTS OF THE DYE STUDY SHOWED THE CATHETER WAS NO LONGER IN THE INTRATHECAL SPACE. THE ISSUE WAS THE CATHETER SLIPPED OUT OF THE INTRATHECAL SPACE, MIGRATION. THE DISTAL END WAS OUT OF THE INTRATHECAL SPACE. THE PATIENT WAS SCHEDULED FOR A CATHETER REVISION (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324589 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention