BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203060 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11223
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 8, 2009
    Report Date
    June 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT TOOK THE HEALTH CARE PROVIDER (HCP) FOUR TIMES TO GET THE CATHETER IN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FURTHER, THE HEALTH CARE PROVIDED REPORTED THAT THE PROCEDURE HAD NOT TAKEN ELEVEN HOURS AND THAT THERE WERE NO ISSUES PLACING THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP IMPLANT PROCEDURE WAS ¿USUALLY¿ A TWO TO FOUR HOUR OUTPATIENT PROCEDURE HOWEVER, THE PATIENT ¿WAS IN THERE ELEVEN HOURS¿. IT WAS REPORTED ¿THE DOCTOR CAME IN AND TOLD ME THEY ALMOST GAVE UP BECAUSE THE WAY HIS BREAK WAS THEY COULDN¿T REALLY GET THE CATHETER THROUGH THERE. AND HE SAID HE WAS GOING TO TRY ONE LAST TIME AND HE GOT IT THROUGH¿. IT WAS NOTED THE REPORTER WAS CONCERNED BECAUSE THE PROCEDURE TOOK ¿ABOUT¿ THREE TIMES LONGER THAN IT SHOULD HAVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302473 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR