BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993648 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09218
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEAD IMPLANT PROCEDURE, THE SINGLE COIL LEAD WAS UNABLE TO RESCUE THE PATIENT DURING DEFIBRILLATION THRESHOLD TESTING. THE PATIENT WAS EXTERNALLY DEFIBRILLATED. THE LEAD WAS REMOVED AND A DUAL COIL LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468723 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR