BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2802857 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09476
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT BEEN "FEELING GOOD". THE PATIENT INDICATED NOT FEELING WELL "LATELY" AND HAD GENERALLY POINTED TO THE ABDOMEN AREA, BUT ACCORDING TO THE HEALTHCARE PROVIDER (HCP) IT WAS UNCLEAR WHETHER THE PATIENT'S SYMPTOM WAS LOCALIZED TO THE AREA AROUND THE PUMP, OR THE LOWER ABDOMEN. THE HCP ORDERED A FLUOROSCOPY AND OBSERVED THAT THE CATHETER APPEARED DISCONNECTED FROM THE PUMP; A RADIOLOGIST ALSO THOUGHT THE CATHETER APPEARED DISCONNECTED. THE HCP REPORTED DIFFICULTY LOCATING THE "CENTER PORT" TO REFILL THE PUMP AND INDICATED THAT THE PUMP WAS 'A BIT TIPPED.' THE HCP FLATTENED OUT THE PUMP AND ATTEMPTED TO FIND THE PORT, BUT SHE REPORTEDLY COULD ONLY FEEL METAL. THE HCP NOTED THAT THERE WAS A GAP THAT LOOKED 'FUZZY," BUT THE PUMP WAS NOT FLIPPED. ANOTHER HCP RECOMMENDED A DYE STUDY TO TROUBLESHOOT THE ISSUE FURTHER. THE PUMP WAS DELIVERING LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1