BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3991828 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07937
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 10, 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE SILICONE MEDICAL ADHESIVE USED TO BACKFILL SPECIFIC SECTIONS OF THE LEAD IS PART OF THE STANDARD OPERATING MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT, THE LEAD WAS INSPECTED WITH NOTED BUBBLES ON THE LEAD INSULATION AND BULGING ON THE DISTAL COIL NEAR THE RING OF THE ELECTRODE. THE LEAD WAS NOT USED FOR IMPLANT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467592 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1