BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070441 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06625
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 25, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING POOR EFFICACY SINCE IMPLANT. IT WAS STATED THAT THE PATIENT'S SPASTICITY HAD NOT IMPROVED AND SHE HAD COMPLAINED OF DROWSINESS AND FATIGUE WITH INCREASED DOSE TITRATIONS. THE PATIENT UNDERWENT A CATHETER DYE STUDY AND THE PHYSICIAN WAS UNABLE TO ASPIRATE THROUGH THE SIDE PORT. IT WAS REPORTED THAT THERE WAS A CATHETER OCCLUSION. IT WAS REPORTED THAT NO ACTION HAD BEEN TAKEN YET, BUT THE PATIENT WOULD BE REFERRED TO THE SURGEON FOR A CATHETER REVISION. THE DEVICE SYSTEM WAS INFUSING LIORESAL. FOUR DAYS LATER, IT WAS REPORTED THAT THERE HAD BEEN NO EXPLANT YET AND NO FURTHER ACTION HAD BEEN TAKEN.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CATHETER HAD AN OCCLUSION HOWEVER, THE LOCATION WAS NOT PROVIDED. AS A RESULT, THE PATIENT WAS HOSPITALIZED AND THE CATHETER WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173010 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Hospitalization| R