BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153731 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06181
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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 FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT AND BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE SCREW MECHANISM ON THE RIGHT VENTRICULAR LEAD APPEARED TO SPRING OUT WHILE TESTING AND DURING IMPLANTATION. THE LEAD WAS TESTED PRIOR TO IMPLANT WITH THE LEAD POSITIONED STRAIGHT AND THE STRAIGHT STYLET FULLY SEATED. THE SCREW IN TOOL WAS ROTATED SLOWLY TO APPROXIMATELY 8-14 TURNS WITH NO OBVIOUS MOVEMENT OF THE SCREW, ALTHOUGH THE LEAD BODY APPEARED TO ROTATE. THEN THE SCREW APPEARED TO 'JUMP OUT' WITH NO OBVIOUS CORRELATION TO STEADY ROTATION. UNDER FLUOROSCOPY, WHEN ATTEMPTING TO IMPLANT THE LEAD, THE SCREW ALSO APPEARED TO JUMP OUT. A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254948 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR