BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973350 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02154
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    April 12, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL#(B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    ON 8/21/2014 INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) INDICATING THAT THE PATIENT¿S PUMP CONTAINED LIORESAL. THE PATIENT HAD SYMPTOMS OF INCREASED SPASTICITY. THERE WAS NO ACUTE WITHDRAWAL. THE CATHETER ISSUE AND LOCATION OF THE ISSUE WERE UNKNOWN. A CT DYE STUDY WAS PERFORMED, BUT THE RESULTS WERE NORMAL. THE CATHETER WAS REPLACED ON (B)(6) 2011. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2017 FROM A LEGAL FIRM INDICATED CATHETER FAILURE HAD OCCURRED (NO SPECIFIC EVENT DATE PROVIDED). THE PATIENT EXPERIENCED SPASTICITY AND PAIN. EXPLANT SURGERY WAS PERFORMED ON (B)(6) 2014. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE INITIAL PUMP THE CATHETER FELL OUT, SO IT HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450615 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention