BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990830 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08457
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WERE NO ANOMALIES OR IRREGULARITIES OBSERVED ON THE INSULATION OF THE RETURNED LEAD. THE SILICONE MEDICAL ADHESIVE USED TO BACKFILL SPECIFIC SECTIONS OF THE LEAD IS PART OF THE STANDARD OPERATING MANUFACTURING PROCESS. INTRODUCER INSERTION TEST PERFORMED WITHOUT DIFFICULTY OR RESISTANCE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD WAS UNABLE TO PASS THROUGH INTRODUCER. UPON INSPECTION OF THE LEAD, IT OBSERVED THERE WAS AN ADDITIONAL RAISED LEVEL ON THE OUTER LEAD INSULATION. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470146 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR