BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3991507 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08073
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVER-SENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), AND CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) WERE MET. 47 OF 51 LIFETIME VENTRICLE-SICS ARE RECORDED BEGINNING (B)(4) 2014, AND A LIA TRIGGERED ON 2014-5-23 DUE TO MEETING THE REQUIREMENTS FOR NONSUSTAINED (NST) TACHYCARDIA AND VENTRICLE-SICS. THERE WERE 4 NST EVENTS OF LESS THAN 220 MILLISECOND VENTRICLE-VENTRICLE CYCLE RECORDED ON (B)(4) 2014. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID 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. CONCOMITANT PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2011. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT TRIGGERED, AND FORTY-SEVEN V-V SHORT INTERVAL COUNTS WERE OBSERVED. FOUR EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA WERE RECORDED DUE TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470342 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R D274DRG ICD