BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3861668 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07205
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: D314TRG, ICD, IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 4 MONTHS AFTER A ROUTINE DEVICE REPLACEMENT, THE RIGHT VENTRICULAR LEAD HIGH VOLTAGE (HV) COIL IMPEDANCES WERE VARYING AND HIGH, AND A LEAD WARNING WAS TRIGGERED. A LOOSE CONNECTION BETWEEN THE DEVICE AND LEAD WAS SUSPECTED. DURING A SCHEDULED LEFT VENTRICULAR EPICARDIAL LEAD IMPLANT PROCEDURE, BOTH HV COIL LEAD PINS WERE RE-INSERTED INTO THE DEVICE HEADER AND THE IMPEDANCES WERE STEADY AT ABOUT 50 OHMS. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341976 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 5076-45 LEAD