BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3983447 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14013
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CHANGE IN THERAPY EFFECT. THERE WAS CONCERN THAT THE PUMP WAS NOT WORKING AT THE TIME OF REPORT ((B)(4) 2014). THE PATIENT COULD NOT VERBALIZE BUT WAS DESCRIBED AS VERY UNCOMFORTABLE, TENSE, TACHYCARDIA, THE PATIENT¿S SKIN WAS GETTING RED AND THEIR BELLY WAS GETTING LARGER. IT WAS NOTED THAT THERE WAS CONCERN THAT THE PATIENT WAS NOT ABLE TO ABSORB MEDICATION. THE PUMP HAD NOT BEEN ALARMING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AT THE TIME OF REPORT. THE PUMP WAS USED TO INFUSE BACLOFEN. IT WAS REPORTED ON THE SAME DAY THAT THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF INCREASED SPASTICITY, AGITATION AND LOOKED DISTRESSED THE NIGHT PRIOR TO REPORT ((B)(4) 2014). IT WAS UNKNOWN WHEN THE ONSET OF SYMPTOMS BEGAN. THE PATIENT WAS NOT ABSORBING THEIR MEDICATION THROUGH THEIR GI TUBE AND IT WAS BACKING UP. THE PATIENT WAS IN THE ICU. IT WAS NOTED THAT THEY DID NOT THINK THE PATIENT¿S THERAPY WAS WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459288 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization