BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 7476235 · Received May 1, 2018

    Report

    Report Number
    2649622-2018-07347
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED. ANALYSIS INDICATED THAT THE EXPOSED SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS FRACTURED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4968 LEAD, IMPLANTED: (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4968 LEAD, IMPLANTED: (B)(6) 2016. 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 LEAD HIGH VOLTAGE (HVB) AND SUPERIOR VENA CAVA (SVC) IMPEDANCES WERE HIGH. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319468 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R (B)(4), 5076 LEAD