BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3991594 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08032
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE INSULATION OF THE RIGHT VENTRICULAR (RV) LEAD WAS IRREGULARLY SHAPED AND BUBBLES IN THE INSULATION WERE OBSERVED. THE LEAD WAS NOT USED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471703 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR