BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3020837 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04220
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8711 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FELL APPROXIMATELY TWO DAYS PRIOR TO THE DATE OF THIS REPORT AND WAS IN THE HOSPITAL. THE PATIENT REPORTED THAT THE PUMP WAS NOT WORKING AND EXPERIENCED INCREASED SPASTICITY, PAIN, AND SHAKING. THE PATIENT'S PAIN WAS LOCATED ACROSS THE LUMBAR SPINE, INTO THE PUMP SITE AND UP THE PATIENT'S BACK. THIS PAIN WAS REPORTED TO HAVE STARTED AFTER THE PATIENT'S FALL. THIS DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122954 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1