BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2920580 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00719
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 23, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, 8711 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH ACUTE RENAL FAILURE AND ELEVATED LIVER ENZYMES. IT WAS SUSPECTED THAT THE INFUSION SYSTEM WAS INTERFERING WITH THE PATIENT'S CARE. THE PATIENT DID NOT HAVE A FEVER, PRUIRITIS, ALTERED MENTAL STATUS, OR INCREASED SPASTICITY. THE DRUG IN THE PUMP WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26311 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization