BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3919647 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-12651
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    November 15, 2013
    Report Date
    June 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 870953, SERIAL# (B)(4), PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ABDOMINAL INFECTION RESULTING IN THE DRUG INFUSION SYSTEM BEING REMOVED/EXPLANTED ON (B)(6) 2014 WITH SOME OF THE CATHETER LEFT IN PLACE. THE PATIENT HAD EXPERIENCED ACUTE INCREASED SPASTICITY BUT WAS PUT ON ORAL BACLOFEN AND HAD BEEN ON THAT FOR MONTHS SINCE (B)(6) 2014. IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED. IT WAS FURTHER PROVIDED THAT THE PRIMARY LOCATION OF THE INFECTION WAS ABDOMINAL. IT WAS NOT KNOWN IF A CULTURE WAS TAKEN OR THE TREATMENT INSTITUTED FOR THE INFECTION. THE PATIENT WAS DOING WELL AND THE INFECTION RESOLVED. THIS DEVICE SYSTEM DELIVERED LIORESAL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS QUITE CONTRACTED AND VERY THIN HOWEVER, THEY IMPLANTED THIS 40ML PUMP. THE INFECTION STARTED AROUND (B)(6) 2013. THE STAPLES WERE REMOVED THAT DAY AND A SIGNIFICANT AMOUNT OF DRAINAGE WAS NOTED. THERE WAS NO FEVER BUT A SMALL SHALLOW OPEN AREA WAS PRESENT AND THEY COULD SEE THE PUMP. THE PUMP NEEDED TO BE EXPLANTED. THE EXPLANTED WAS NOW REPORTED TO HAVE OCCURRED ON (B)(6) 2014. THIS EXPLANTED PUMP, WHICH WAS NOW ALARMING WAS TO BE PROGRAMMED OFF AND WAS NOT GOING TO BE RETURNED. A NEW PUMP WAS LATER IMPLANTED ON (B)(6) 2014. THE PATIENT WAS NOW RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397607 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R