BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3860148 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05548
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE RIGHT VENTRICULAR (RV) LEAD WAS INITIALLY PLACED, THE PHYSICIAN ATTEMPTED TO PLACE THE ATRIAL LEAD, BUT FOUND THE INITIAL ACCESS TO BE SUBOPTIMAL. UPON ATTEMPTING TO LOCATE A MORE FAVORABLE ACCESS, THE PHYSICIAN ACCIDENTALLY DAMAGED THE INSULATION ON THE RV LEAD. THE LEAD WAS SUBSEQUENTLY REMOVED AND A NEW LEAD WAS PLACED. ADDITIONALLY, WHILE ATTEMPTING TO SUTURE THE SECOND RV LEAD INTO PLACE, THE INSULATION WAS DAMAGED ON THE SECOND LEAD AS WELL. THE RV LEAD WAS REMOVED AND A NEW LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337052 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR