BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4221301 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20868
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8598A, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE PUMP HAD BEEN EMPTY FOR SEVERAL MONTHS, THOUGH IT WAS DONE BY DESIGN. THE PATIENT HAD BEEN TITRATED DOWN AND WAS BEING MANAGED OUTSIDE OF THE PUMP. IT WAS NOTED THAT THERE HAD BEEN NO MEDICAL OR PUMP PROBLEM. THE HEALTHCARE PROVIDER (HCP) PLANNED TO PROGRAM THE PUMP TO MINIMUM RATE MODE. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP HAD BEEN EMPTY AS OF (B)(6) 2014. THE INTRATHECAL BACLOFEN WAS NOT EFFECTIVE. THE PATIENT DID NOT SHOW UP FOR A FOLLOW-UP APPOINTMENT FOR AT LEAST 8 MONTHS. THERE WAS POOR COMPLIANCE WITH FOLLOW-UP AND THE PATIENT PREFERRED THE PUMP TO BE REMOVED. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701458 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1