BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5039225 · Received August 28, 2015

    Report

    Report Number
    3004209178-2015-16927
    Event Type
    Injury
    Date Received
    August 28, 2015
    Report Date
    July 28, 2016
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8 590-1, LOT# N142172, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, LOT# L71610, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED THE DATE OF EXPLANT WAS (B)(6) 2013. IT WAS NOT CLARIFIED WHICH COMPONENT WAS EXPLANTED.

    Description of Event or Problem · 1

    CORRECTION: DATE OF PUMP EXPLANT WAS (B)(6) 2013.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING THE DELIVERY OF AN UNKNOWN DRUG (DEVICE REGISTRY LISTS THE DRUG AS LIORESAL) IN AN INTRATHECAL INFUSION PUMP FOR INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. THE PUMP WAS REMOVED BECAUSE THE "LINE" BROKE. THIS RESULTED IN THE PATIENT BEING "FULL OF PUS" AND INFECTION. THE DATE OF THE EXPLANT WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED FORM THE HEALTHCARE PROVIDER (HCP) REGARDING DRUG INFORMATION, CONCOMITANT DRUGS, PERTINENT MEDICAL HISTORY, WHEN THE CATHETER BREAK OCCURRED, WHAT SYMPTOMS THE PATIENT EXPERIENCED, ANY TROUBLESHOOTING, THE CAUSE OF THE CATHETER BREAK, AND IF THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570811 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention