BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT PL PEELABLE OUTER CATHETER

    MDR report key: 3567034 · Received January 9, 2014

    Report

    Report Number
    2017865-2014-04091
    Event Type
    Injury
    Date Received
    January 9, 2014
    Date of Event
    November 22, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DQY
    PMA / PMN Number
    K061710
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BI-VENTRICULAR IMPLANT, THE CORONARY SINUS WAS PERFORATED. THE PATIENT WAS MEDICALLY MANAGED AND OBSERVED IN THE INTENSIVE CARE UNIT. LEAD REPLACEMENT WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15183 DIRECT PL PEELABLE OUTER CATHETER ACCESSORY DQY ST. JUDE MEDICAL, INC., CRMD 410173 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention