BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4833762 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06965
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 9, 2015
    Report Date
    April 9, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS INDICATED THAT THE EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE RV COIL IS PULLED TOWARDS THE DISTAL END OF THE LEAD INDICATING THE LEAD WAS WITHDRAWN FROM A HEMOSTASIS VALVE. THE VALVE IS DESIGNED TO BE A ONE WAY VALVE WITH THE LEAD INSERTED AND THE VALVE SLIT OFF TO BE REMOVED. WITHDRAWING THE LEAD FROM THE VALVE CAN DAMAGE THE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN INDICATED THAT THE INSERTION OF THE SHEATH INTO THE VESSEL WAS DIFFICULT AS IT WAS VERY TIGHT. AS THE LEAD WAS INTRODUCED INTO THE SHEATH, IT BECAME DIFFICULT TO PUSH THE LEAD FORWARD. UPON REMOVING THE LEAD, THE DISTAL END OF THE COIL APPEARED TO BE DAMAGED. ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN INDICATED THAT THE INSERTION OF THE SHEATH INTO THE VESSEL WAS DIFFICULT AS IT WAS VERY TIGHT. AS THE LEAD WAS INTRODUCED INTO THE SHEATH, IT BECAME DIFFICULT TO PUSH THE LEAD FORWARD. UPON REMOVING THE LEAD, THE DISTAL END OF THE COIL APPEARED TO BE DAMAGED. ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376168 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR