BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800074 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08722
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 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 PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS OCCLUDED AND A REVISION WAS DONE. PER THE REPORTER THE CATHETER WAS EITHER KINKED OR OCCLUDED. THE CATHETER WAS REPLACED WITH AN 8780 ASCENDA CATHETER. IT WAS NOT KNOWN IF THERE WAS ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED.THE PATIENT EXPERIENCED INCREASED SPASTICITY. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS INDICATED AS ALIVE, NO INJURY. THE PUMP WAS USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION LATER REPORTED THE LOCATION OF THE KINK WAS NOT ESTABLISHED. NO FURTHER ACTION HAVE BEEN TAKEN OR WOULD BE DONE. THE PATIENT HAS RECOVERED AND WAS RECEIVING GOOD THERAPEUTIC EFFECT, SPASTICITY WAS WELL MANAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278660 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention