BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2790553 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15346
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    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

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED. THERE WERE TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(4) 2010 19:28:48 AND (B)(4) 2012 11:18:08. THERE WAS OVERSENSING, AS THERE WERE ELEVEN VENTRICULAR NST LESS THAN OR EQUAL TO 213 MS ON (B)(4) 2012 IN THE TIMEFRAME BETWEEN 10:28:10 AND 11:19:32.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD OVERSENSING, NOISE, AND THE LEAD INTEGRITY ALERT WAS TRIGGERED. THE LEAD WILL NOT BE REVISED BECAUSE THE PATIENT NO LONGER NEEDS THE SYSTEM AND THE SYSTEM WAS PROGRAMED OFF. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention D234VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D234VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB