BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1052368 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02835
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AN OVERDOSE WAS REPORTED. THE PT WAS HYPOTENSIVE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID. THE HCP WANTED TO TURN THE PUMP OFF. NO OTHER CLINICAL OR DEVICE INFO WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| LEFT VENTRICULAR LEAD MODEL# 419478| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEUROSTIMULATOR MODEL# 7425| CARDIAC LEAD MODEL# 694958| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| PROGRAMMER MODEL 7434-E LOT# YN0032387P| EXPLANTED:| CATHETER MODEL 8703W LOT# L53270| IMPLANTABLE PULSE GENERATOR MODEL# 7299| LEAD MODEL# 3888-45| EXPLANTED:| CARDIAC LEAD MODEL# 5076-45| IMPLANTED:| EXTENSION MODEL# 7495-51| EXPLANTED:| IMPLANTED:| IMPLANTED: