BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090559 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17059
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED A LOSS OF THERAPY AND INCREASED SPASTICITY AND IT WAS UNKNOWN WHEN THIS BEGAN. IT WAS NOTED A CATHETER REVISION WAS BEING DONE ON THE DATE OF THIS REPORT AND THE EXISTING ASCENDA CATHETER WAS BEING LEFT IN PLACE. IT WAS FURTHER REPORTED THE CATHETER ISSUE AND LOCATION OF THE CATHETER ISSUE WAS UNKNOWN. IT WAS NOTED A MICRO TEAR OR OTHER UNKNOWN ISSUES SUSPECTED, BUT UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF) FROM THE CATHETER WHEN CUT AT THE SPINE. A NEW 8781 CATHETER WAS IMPLANTED AND THE OLD SPINAL SEGMENT WAS LEFT IN THE INTRATHECAL SPACE. THE PATIENT¿S DOSE WAS REDUCED BY 85% TO 150MCG/DAY AND NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT¿S OUTCOME. THE PUMP WAS BEING USED TO DELIVER BACLOFEN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570461 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention