BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2864890 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17554
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. VISUAL ANALYSIS NOTED THAT THE LEAD HELIX EXTENDED AND RETRACTED WITHOUT ISSUE AND WITHIN SPECIFICATION. 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 PRIOR TO THE IMPLANT PROCEDURE, THE HELIX WAS UNABLE TO ADVANCE IN THE RIGHT VENTRICULAR LEAD. THE LEAD WAS NOT IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR