BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LV LEAD

    MDR report key: 8685430 · Received June 10, 2019

    Report

    Report Number
    2938836-2019-04641
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    CORRECTION: NEW INFORMATION STATES THAT THERE WAS NO ALLEGATION AGAINST THE CRTD SYSTEM. DISSECTION OF THE CORONARY SINUS HAPPENED DURING CANNULATION TENTATIVE OF THE CORONARY SINUS. DISSECTION HAPPENED WHILE USING THE CANNULATOR WHICH IS REPORTED IN MANUFACTURER REPORT NUMBER 2182269-2019-00055.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBERS: 2938836-2019-04637, 2938836-2019-04638, AND 2938836-2019-04640. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS A CORONARY SINUS DISSECTION. THERE WAS NO COMPLICATION DUE TO THE DISSECTION. THE PATIENT WAS DISCHARGE AFTER AN OVERNIGHT OBSERVATION ON (B)(6) 2019. THE PATIENT WAS DOING WELL BEFORE DURING AND AFTER THE EVENT. IT WAS UNKNOWN WHICH PRODUCT CAUSED THE DISSECTION.

    Description of Event or Problem · 1

    NEW INFORMATION STATES THAT THERE WAS NO ALLEGATION AGAINST THE CRTD SYSTEM. DISSECTION OF THE CORONARY SINUS HAPPENED DURING CANNULATION TENTATIVE OF THE CORONARY SINUS. DISSECTION HAPPENED WHILE USING THE CANNULATOR WHICH IS REPORTED IN MANUFACTURER REPORT NUMBER 2182269-2019-00055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477372 LV LEAD LV LEAD LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LV LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention