BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3922112 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12693
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE; CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GRADUALLY OVER THE LAST FEW WEEKS THE PATIENT HAD BEEN REPORTING INCREASE IN PAIN. THE HCP DID A DYE STUDY THE DAY OF THE REPORT AND COULD NOT ASPIRATE FROM THE CAP. THE HCP SUSPECTED ¿SCARRING OR GRANULOMA¿ AT THE TIP OF THE CATHETER AND PLANNED TO REVISE THE CATHETER. THE REPORTER WAS NOT AWARE OF ANY DIAGNOSTICS HAD BEEN ORDERED TO CONFIRM IF IT WAS A GRANULOMA OR NOT. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND DILAUDID. ADDITIONAL INFORMATION LATER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THE EVENT WAS ATTRIBUTED TO THE CATHETER; OCCLUSION. TROUBLESHOOTING ALSO INCLUDED DOSE ADJUSTMENTS. THE PATIENT WAS INDICATED AS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401179 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention