BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990622 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08564
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. 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. CONCOMITANT PRODUCTS: 419478 LEAD IMPLANTED (B)(6) 2009; DTBB1D1 ICD IMPLANTED (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED AND ANALYZED. ANALYSIS OF THE DATA INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER).THE DATA ALSO INDICATED A LEAD NOISE ALERT ON (B)(6) 2014 AND THAT THE CRITERIA FOR THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT WERE MET. 9731 OF 16034 LIFETIME VENTRICULAR SIC ARE RECORDED BEGINNING (B)(6) 2014. A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2014 DUE TO MEETING THE REQUIREMENTS FOR NON-SUSTAINED EPISODES AND VENTRICULAR SIC. THERE ARE 14 NON-SUSTAINED EPISODES AND 5 LEAD FAILURE PREDICTOR EVENTS OF <(><<)> 220 MS CYCLE LENGTH RECORDED ON (B)(6) 2014.

    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 THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING NOISE AND OVERSENSING IN THE FORM OF SHORT INTERVAL COUNTS (SIC). THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467882 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5076-52 LEAD