BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3861657 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07208
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIB RILLATION COIL 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 THE NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD MEASUREMENTS WORSENED ONCE THE SUTURE SLEEVE WAS FIXATED. AN ATTEMPT WAS MADE TO REPOSITION THE LEAD BUT COULD NOT BE DONE SMOOTHLY AS THE SHEATH HAD ALREADY BEEN REMOVED AND THE PATIENT HAD A TORTUOUS ANATOMY. IT WAS DECIDED TO REMOVE THE LEAD AND MAKE ANOTHER ATTEMPT WITH A NEW DELIVERY SYSTEM. AS THE LEAD WAS BEING REMOVED, THE SUPERIOR VENA CAVA (SVC) COIL BECAME CAUGHT AT THE SITE OF VENOUS ACCESS AND COULD NOT BE REMOVED WITHOUT FORCE. THE LEAD WAS ULTIMATELY ABLE TO BE REMOVED BUT THE SVC COIL WAS NO LONGER VIABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341507 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1