BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993539 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09242
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL ATTEMPTED STYLETS COULD ONLY BE ADVANCED HALFWAY DOWN THE ATTEMPTED RIGHT VENTRICULAR (RV) LEAD AND COULD NOT BE ADVANCED ANY FURTHER. THE LEAD WAS REMOVED AND A STYLET COULD BE INSERTED SUCCESSFULLY. A SECOND IMPLANT ATTEMPT WITH THE SAME LEAD WAS THEN MADE BUT DIFFICULTY ADVANCING THE STYLET WAS EXPERIENCED AGAIN. THE LEAD WAS REMOVED AND A SECOND LEAD WAS ATTEMPTED. THE SAME ISSUE WAS EXPERIENCED WITH THE SECOND LEAD THAT WAS ULTIMATELY IMPLANTED BUT THERE WAS LESS DIFFICULTY ADVANCING THE STYLET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467389 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR