BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3073207 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06773
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8575, LOT# J0321971R, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL ON (B)(6) 2013 DUE TO HAVING THE FLU. PER THE REPORTER, THE PUMP WAS DUE TO BE EMPTY AS OF (B)(6) 2013, AND THE ALARM WAS EXPECTED BY THE PATIENT ON (B)(6) 2013, BUT NO ALARM WAS HEARD. THE PATIENT NOTED LISTENING TO THE PUMP WITH A STETHOSCOPE AND STILL DID NOT HEAR AN ALARM. THE PATIENT INDICATED HE WAS GETTING PAIN RELIEF, BUT WAS CONCERNED THAT THE PUMP SHOULD POSSIBLY BE ALARMING AND WAS NOT. NO FURTHER INFORMATION WAS REPORTED. THE PATIENT NOTED THE PUMP TO BE A "PAIN PUMP", BUT SPECIFIC DRUGS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174227 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR