BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 6170624 · Received December 13, 2016

    Report

    Report Number
    2017865-2016-07787
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    June 29, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD WAS NOT IMPLANTED DUE TO PHRENIC NERVE STIMULATION.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT IS STABLE AND DOING WELL AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819734 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 A000020220

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention