BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2823036 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-10007
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    February 21, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAD SPINAL HEADACHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER IMPLANT SITE HAD LEAKED "DIRECTLY AFTER IMPLANT". THE PATIENT HAD TO RECEIVE "PLASMA PLUGS" TWICE. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN AND DILAUDID (HYDROMORPHONE). NO FURTHER INFORMATION WAS PROVIDED ON THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON 2017-FEB-17. IT WAS REPORTED THAT THE PATIENT WAS TALKING ABOUT A SPINAL LEAK BECAUSE THE HEALTHCARE PROFESSIONAL (HCP) UTILIZED ¿TOO BIG OF A NEEDLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention