BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990952 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08403
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE BEND IN THE DISTAL COIL WAS LIKELY THE DISTORTED/BENT STYLET THAT WAS IN THE LEAD. AFTER THE STYLET WAS REMOVED FROM THE LEAD, THE LEAD DID NOT APPEAR BENT. THE STYLET WAS LIKELY DISTORTED DURING THE ATTEMPTED IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BEND OR BUCKLE WAS OBSERVED IN THE DISTAL COIL OF THE HIGH VOLTAGE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS NOT ATTEMPTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471452 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR