BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3160223 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07967
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS FOUND THAT THE EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL DISTAL ELECTRODES SHOWED A WHITE SUBSTANCE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE FOR THE IMPLANTABLE DEFIBRILLATION LEAD A "WHITE RESIDUE ON THE RV COIL" WAS OBSERVED. AS THE DOCTOR DID NOT KNOW WHAT THE MATERIAL WAS THEY DID NOT WANT TO IMPLANT THE LEAD. THE LEAD WAS NOT USED ON THE PATIENT. A DIFFERENT LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260665 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1