BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3170978 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10419
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731, LOT# B005308N27, IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ACTUAL RESIDUAL VOLUME IS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THE HEALTHCARE PROVIDER (HCP) WAS GETTING SOME HIGHER REFILL VOLUMES THE LAST COUPLE OF REFILLS. THE SPECIFIC VALUES FOR VOLUMES WERE NOT KNOWN BY THE REPORTER. THE PUMP WAS USED TO DELIVER GABLOFEN. IT WAS LATER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN, ALTHOUGH THERE WAS NO PROGRAMMING ISSUE. THEREWERE NO SIGNS OR SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271196 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1