BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3962241 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13619
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 2, 2014
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS EVALUATED VIA A DYE STUDY, AND WAS FOUND TO HAVE BEEN KINKED. SUBSEQUENTLY, ON (B)(6) 2014, THE CATHETER WAS REPLACED, AND THE PUMP WAS ALSO REPLACED BECAUSE IT WAS THOUGHT TO HAVE BEEN CLOSE TO ITS REPLACEMENT TIME BY THE HEALTH CARE PROVIDERS (HCPS) AND FAMILY. THE PUMP LOGS WERE READ AND THEY REVEALED NO PUMP STALLS THROUGHOUT THE LIFE OF THE PUMP. ADDITIONALLY, IT WAS NOTED THAT THE PUMP WAS FUNCTIONING NORMALLY AS PER TELEMETRY, FAMILY, AND PROVIDERS. AS OF THE DATE OF THE REPORT, THE PATIENT WAS ALIVE AND WITHOUT INJURY, THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THAT EVENT, AND THE PRODUCT ISSUE WAS NOTED TO HAVE BEEN RESOLVED. THE PUMP WAS BEING USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439470 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Required Intervention