BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4242104 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03285
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) HAD PERFORMED A (B)(6) STUDY AND WAS UNABLE TO DETERMINE WHERE THE CATHETER WAS. CATHETER MIGRATION/DISLODGEMENT WERE REPORTED. THE HCP EMPTIED THE PUMP AND WANTED THE PUMP STOPPED. THE MANUFACTURER REPRESENTATIVE PROGRAMMED AND STOPPED THE PUMP/TURNED OFF. X-RAYS WERE PERFORMED AND SURGICAL INTERVENTION WAS PLANNED. THE PUMP WAS USED TO DELIVER COMPOUNDED BACLOFEN. THE OUTCOME OF THE EVENT WAS UNKNOWN. 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
    721952 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention