BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6164248 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-16065
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: D334DRM ICD IMPLANTED: (B)(6) 2012; 5076-45 LEAD, IMPLANTED: (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION RECEIVED FROM THE AUTHOR AND THE COMPANY RE PRESENTATIVE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. REFERENCED ARTICLE: FEASIBILITY OF DEFIBRILLATION AND PACING WITHOUT TRANSVENOUS LEADS IN A COMBINED MICRA AND S-ICD SYSTEM FOLLOWING LEAD EXTRACTION. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2017;28(2):233-234. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A CONFIRMED FRACTURE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH A JOURNAL ARTICLE AND THE SUBSEQUENT FOLLOW UP RECEIVED FROM THE AUTHOR AND THE COMPANY REPRESENTATIVE. THE ARTICLE REPORTED THAT THE LEAD HAD FRACTURED. THE AUTHOR INDICATED THAT THE FRACTURE WAS ¿POTENTIALLY RELATED TO THE TETHERING OF TWO LEADS (FROM THE DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO THE TRICUSPID VALVE.¿ THE LEAD WAS EXTRACTED VIA LASER-ASSISTANCE. THE PATIENT WAS SUBSEQUENTLY IMPLANTED WITH A TRANSCATHETER PACEMAKER AND A ¿FULLY SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)¿ AT THE SAME TIME. THE AUTHOR REPORTED THAT THE TWO SYSTEMS WERE ¿FUNCTIONING OPTIMALLY WITHOUT ANY INDICATION OF ADVERSE DEVICE TO DEVICE INTERACTION.¿ NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810092 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R