BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6319475 · Received February 9, 2017

    Report

    Report Number
    2649622-2017-02082
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    November 4, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4543 LEAD, IMPLANTED: (B)(6) 2008-11-06. 5568-53 LEAD, IMPLANTED: (B)(6) 2006.

    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 THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV DEFIBRILLATION IMPEDANCE. THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101299 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR D314TRG ICD