BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991498 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08084
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE PHYSICIAN EXPRESSED GREAT DIFFICULTY PASSING THE STYLETS THROUGH THE LUMEN OF THE RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, IT WAS NOTED THAT THE HELIX OF THE LEAD WOULD NOT DEPLOY AFTER MULTIPLE ATTEMPTS AT TURNING THE ROTATION TOOL. THE RV LEAD WAS REMOVED AND REPLACED. THE REPLACEMENT LEAD EXHIBITED THE SAME DIFFICULTIES PASSING THE STYLET THROUGH THE LUMEN OF THE LEAD, HOWEVER WAS SUCCESSFULLY PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470339 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR DVBB1D4 ICD