BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811090 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16581
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL CONDUCTOR WAS FRACTURED, THE HIGH VOLTAGE COILS WERE STRETCHED, THE OUTER INSULATION WAS TORN, THE DISTAL ELECTRODE WAS COVERED IN BLOOD, AND THERE WAS BLOOD ON THE HIGH VOLTAGE COILS; FULL LEAD RETURNED AND ANALYZED. ANALYSIS OF PERFORMANCE DATA FOUND 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 19:40:21. VENTRICULAR SHORT INTERVAL COUNT V-SIC=33 COUNTS, IN 0.86 DAY, BETWEEN (B)(6) 2012 018:15:24 AND (B)(6) 2012 14:48:04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO THE LEAD INTEGRITY ALERT BEING TRIGGERED.THE LEAD WAS FOUND TO HAVE SHORT INTERVAL COUNTER AT SEVENTEEN.THE PHYSICIAN WAS ABLE TO REPRODUCE THE PROBLEM DURING THE PROCEDURE AND DECIDED TO REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO THE LEAD INTEGRITY ALERT BEING TRIGGERED. THE LEAD WAS FOUND TO HAVE SHORT INTERVAL COUNTER AT SEVENTEEN. THE PHYSICIAN WAS ABLE TO REPRODUCE THE PROBLEM DURING THE PROCEDURE AND DECIDED TO REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R