BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 8806900 · Received July 19, 2019

    Report

    Report Number
    8806900
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 2, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) CHANGE-OUT AND LASER LEAD EXTRACTION OF RIGHT VENTRICULAR QUATTRO LEAD ON [DATE REDACTED]. THE QUATTRO LEAD HAD EARLIER BEEN DETERMINED TO BE FRACTURED FOUR YEARS AGO, BUT THE PATIENT HAD A FOUR-YEAR DELAY IN SEEING HIS CARDIOLOGIST UNTIL RECENTLY. DEVICE INTERROGATION (FOUR YEARS AGO) FINDS BATTERY AT 2.65V, SPRINT QUATTRO WITH HIGH IMPEDANCE, HIGH FREQUENCY RR INTERVALS CONSISTENT WITH LEAD FRACTURE. ALL TEN SHOCKS REVIEWED, ALL INAPPROPRIATE. H&P: "PATIENT IS A MALE WITH A HISTORY OF FAMILIAL SUDDEN CARDIAC DEATH (SCD) AND LONG QT SYNDROME TYPE 2 (LQTS2) WHO UNDERWENT PROPHYLACTIC ICD IMPLANTATION BY___ PEDIATRIC ELECTROPHYSIOLOGY WHO PRESENTS WITH MULTIPLE ICD SHOCKS. UPON DEVICE INTERROGATION, IT WAS FOUND THAT ALL SHOCKS WERE INAPPROPRIATE AND DUE TO SIGNAL ARTIFACT. HE HAS A SPRINT QUATTRO LEAD AND REPORTS NO KNOWN TRAUMA, ALTHOUGH HE DOES REPORT FALLING THROUGH A CEILING AND CATCHING HIMSELF IN BETWEEN TWO RAFTERS. HE REPORTS NO PRIOR LOSS OF CONSCIOUSNESS, NO HISTORY OF APPROPRIATE ICD THERAPY. HE REPORTS HE WAS TESTED, IDENTIFIED AS LQTS GENOTYPE 2, AND BECAUSE OF A PERSONAL DESIRE TO AVOID BETA-BLOCKERS, WAS OFFERED AN ICD." THE PATIENT WAS DISCHARGED HOME, TO FOLLOW-UP WITH THE IMPLANTING CARDIOLOGIST. CARDIOLOGY NOTE: THE PATIENT'S DEVICE INTERROGATION AT THAT OFFICE VISIT WITH DOCTOR SHOWED AN IMPEDANCE OF GREATER THAN 3000 OHMS ON THE RIGHT VENTRICULAR LEAD. THE PATIENT PACES 2% OF THE TIME FROM THE ATRIAL LEAD. THE PATIENT UNDERWENT THE CHANGE-OUT OF THE ICD AND LASER LEAD EXTRACTION WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600627 SPRINT QUATTRO PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 10220 DA