BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2532623 · Received April 12, 2012

    Report

    Report Number
    2649622-2012-04793
    Event Type
    Injury
    Date Received
    April 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) AND THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. THERE WERE 2 NON-SUSTAINED TACHYCARDIA (NST) EPISODES OF LESS THAN 220 MS VENTRICULAR TO VENTRICULAR CYCLE ARE RECORDED ON 12 OCT AND 07 NOV 2013. 555 OF 2021 LIFETIME VENTRICULAR-SIC OCCUR SINCE 11 MAR 2013. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON 19 NOV 2013 DUE TO MEETING THE CONDITIONS FOR NST AND VENTRICULAR-SIC. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING: 7 - VENTRICULAR NST<=200 MS BETWEEN (B)(6)-2011 12:38:08 AND (B)(6)-2011 17:33:49.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT AND RIGHT VENTRICULAR LEADS WERE OVERSENSING AND THAT THERE WERE NON-SUSTAINED TACHYCARDIA EPISODES NOTED. IT WAS ALSO REPORTED THAT THEY WERE ABLE TO REPRODUCE THE NOISE BY REACHING THE LEFT ARM ACROSS THE RIGHT LEG. THE LEADS WERE REPROGRAMMED AND REMAIN 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
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB