BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2971613 · Received February 21, 2013

    Report

    Report Number
    2649622-2013-02462
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT T WAVE OVERSENSING CONTINUED TO OCCUR AND THAT UNDERSENSING WAS ALSO PRESENT. THE LEAD SENSING VECTOR WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. A PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2013. VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 140 MILLISECONDS OCCURRED BETWEEN (B)(6) 2013. VENTRICULAR FIBRILLATION EQUAL TO 160 MILLISECONDS AVERAGE VENTRICULAR CYCLE OCCURRED ON (B)(6) 2012. NON-SUSTAINED HIGH RATES LESS THAN OR EQUAL TO 207 MILLISECONDS AVERAGE VENTRICULAR CYCLE OCCURRED BETWEEN (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALERT OCCURRED RELATED TO LEAD NOISE AND T WAVE OVERSENSING. THERAPY WAS APPROPRIATELY WITHHELD. THE PATIENT WAS BROUGHT TO THE CLINIC FOR A TREADMILL TEST TO REPRODUCE THE OVERSENSING. OVERSENSING WAS ABLE TO BE REPRODUCED AT A HEART RATE OF 155 BEATS PER MINUTE. THE SENSITIVITY WAS DECREASED AND RESOLVED THE OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALERT OCCURRED RELATED TO LEAD NOISE AND T WAVE OVERSENSING. THERAPY WAS APPROPRIATELY WITHHELD. THE PATIENT WAS BROUGHT TO THE CLINIC FOR A TREADMILL TEST TO REPRODUCE THE OVERSENSING. OVERSENSING WAS ABLE TO BE REPRODUCED AT A HEART RATE OF 155 BEATS PER MINUTE. THE SENSITIVITY WAS DECREASED AND RESOLVED THE OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76436 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR