BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2972069 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02943
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED THE CATHETER BODY WAS DEFORMED IN SHAPE OR ABRADED WHICH DID NOT IMPACT INFUSION. AN AREA OF ABRASION WAS SEEN DISTAL TO THE ANCHOR AND 18.5 TO 20 CENTIMETERS FROM THE DISTAL TIP. DUE TO THE AREA OF THIS ABRASION, IT WAS FELT THIS MAY HAVE BEEN CAUSED BY THE PATIENT'S ANATOMY. THIS ABRASION WAS NOT DEEP TO THE INNER LUMEN AND NO LEAKING WAS SEEN. THIS AREA WAS NOT COMPRESSED AND AN OCCLUSION IN THIS AREA WAS NOT LIKELY. THIS ANOMALY WAS NOT RELATED TO THE MANUFACTURE OF THE CATHETER. IN ADDITION, LIGHT COLORED MATERIAL IN THE MOST PROXIMAL SET OFF DISPENSING HOLES WAS OBSERVED. HOWEVER, THIS MATERIAL DID NOT APPEAR TO IMPACT FLOW AS THE LEAD WAS PATENT DURING ANALYSIS TESTING. THE MATERIAL SEEN MAY HAVE CRYSTALIZED IN THAT LOCATION AFTER EXPLANT. IN CONCLUSION, WITH THE INFORMATION PROVIDED, ANALYSIS COULD NOT DETERMINE WITH CERTAINTY IF THE PORTION OF THE CATHETER RETURNED WAS RELATED TO THE EVENT ALLEGATION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8711 LOT# SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4) ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DEVICE 'STOPPED WORKING'. THE PATIENT EXPERIENCED INCREASED PAIN. THE SYSTEM WAS EXPLANTED AT THE PATIENT'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77170 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention