BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4152922 · Received October 8, 2014

    Report

    Report Number
    3007566237-2014-02884
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID NEU_ UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEW SYSTEM WAS IMPLANTED ON THE DAY OF THE REPORT AND THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC AFTER THE SURGERY. THE SURGEON WANTED THE PUMP TO BE SHUT OFF UNTIL HE WAS FINISHED WITH THE CURRENT CASE HE WAS IN. THE PUMP WAS LIKELY TO BE STOPPED FOR 3 HOURS. IT WAS DETERMINED THAT THE CATHETER WAS OBSTRUCTED AND SUBSEQUENTLY REPLACED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632141 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention