BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070193 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06617
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD A ROUTINE PUMP REFILL ON 2013 (B)(6) AT WHICH TIME THE AMOUNT OF MEDICATION WITHDRAWN FROM THE PUMP WAS THE EXPECTED AMOUNT. THE HCP AT THE REFILL CLINIC WAS UNAWARE OF THE OVERDOSE AND ER VISIT IN MARCH. AT THE REFILL THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE EMERGENCY ROOM (ER) WITH SYMPTOMS OF OVERDOSE. THE PATIENT ARRIVED IN THE ER WITH SYMPTOMS OF LETHARGY BUT WAS AROUSE ABLE. THE PATIENT HAD A COMPLETE NEUROLOGICAL WORKUP WHICH WAS NEGATIVE AND THE ER HEALTHCARE PROVIDER (HCP) INDICATED THAT THE PATIENT BELIEVED HE WAS GETTING TOO MUCH DRUG. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172285 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other