BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 9471083 · Received December 15, 2019

    Report

    Report Number
    2017865-2019-17984
    Event Type
    Injury
    Date Received
    December 15, 2019
    Date of Event
    December 4, 2019
    Report Date
    January 8, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734503198
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN ONE PIECE. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. VISUAL INSPECTION AND X-RAY EXAMINATION OF THE LEAD DID NOT FIND ANY ANOMALIES. THE S-CURVE HUMP HEIGHT WAS MEASURED TO BE WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-17983, 2017865-2019-17985. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT. THE RIGHT VENTRICULAR LEAD (RV), RIGHT ATRIAL (RA) LEAD, AND LEFT VENTRICULAR (LV) LEAD WERE PLACED AND RESTED APPROPRIATELY. DURING PROCEDURE, FLUOROSCOPY TESTING TO CHECK FINAL LEAD PLACEMENT NOTED THE RV LEAD WAS NO LONGER IN ITS ORIGINAL POSITION. RIGHT VENTRICULAR PERFORATION WAS NOTED. THE PATIENT SUBSEQUENTLY DEVELOPED TACHYCARDIA AND HYPOTENSION. THE PHYSICIAN SUSPECTED TAMPONADE, AND TAMPONADE WAS CONFIRMED WITH INTRAOPERATIVE ECHOCARDIOGRAM. FURTHERMORE, NO PULSE WAS DETECTED AND ACLS PROTOCOL WAS IMITATED. PERICARDIOCENTESIS WAS PERFORMED AND TAMPONADE WAS RELIEVED. THE PATIENT¿S VITAL SIGNS WERE STABILIZED. THE ORIGIN OF THE TAMPONADE WAS NOT ENTIRELY KNOWN. THE PHYSICIAN FELT THE RV LEAD PERFORATED THE RIGHT VENTRICLE BUT DID NOT FELT IT WAS A RESULT OF THE LEAD ITSELF BUT POSSIBLY THAT THE RV LEAD COULD HAVE BEEN ADVANCED DURING PLACEMENT OF THE LV LEAD. ALL THE LEADS WERE REMOVED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265577 QUARTET PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1458Q/86 A000086292 05414734503198

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention