BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 9638501 · Received January 28, 2020

    Report

    Report Number
    2017865-2020-01036
    Event Type
    Injury
    Date Received
    January 28, 2020
    Report Date
    February 27, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: INFORMATION RECEIVED INDICATES THE LEAD INVOLVED WAS A RIATA LEAD AND NOT A QUICKSITE LV LEAD AND THE SERIAL # IS UNKNOWN. SERIAL # UPDATED FROM (B)(4) TO UNKNOWN LEAD SERIAL (B)(4). CORRECTION: MODEL NUMBER UPDATED FROM QUICKSITE LV 1056T/86 TO RIATA LEAD 1591/65. CORRECTION: LOT NUMBER, EXPIRATION DATE, UDI SHOULD BE BLANK. CORRECTION: PMA NUMBER UPDATED FROM P030054 TO P950022. CORRECTION: MANUFACTURING DATE SHOULD BE BLANK CORRECTION: UPDATED FROM Z-1483-2012 TO Z0457.

    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.

    Description of Event or Problem · 1

    IT WAS NOTED THAT A DECREASE IN IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD. EXTERNALIZATION OF CONDUCTORS WAS CONFIRMED. THE RIGHT VENTRICULAR LEAD WAS SCHEDULED FOR EXTRACTION (B)(6) 2020 TOGETHER WITH A ROUTINE GENERATOR CHANGE. DURING THE PROCEDURE, THE LEAD WAS NOT ACCESSIBLE FOR EXTRACTION AND WAS ABANDONED. A NEW LEAD WAS IMPLANTED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101344 QUICKSITE LV DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1591/65 2964034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention