BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4100062 · Received September 18, 2014

    Report

    Report Number
    3004209178-2014-17335
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEADACHE THAT AFFECTED THE NECK AND SHOULDERS. THE CAUSE OF THE HEADACHE WAS UNKNOWN. THE PATIENT¿S STATUS AT THE TIME OF THE EVENT WAS SAID TO BE ALIVE AND NO INJURY. A BLOOD PATCH WAS PERFORMED AND THE PATIENT WAS FINE NOW. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578539 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention