BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3160301 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07954
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 15, 2013
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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 THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). TWO LEAD FAILURE PREDICTOR EPISODES OF <(> <<)> 220 MS CYCLE LENGTH WERE RECORDED ON (B)(6) 2011 AND (B)(6) 2012. VENTRICULAR PACING IMPEDANCE ROSE FROM AN APPROXIMATE BASELINE OF 525 OHMS THE WEEK ENDING (B)(6) 2011 TO GREATER THAN 1100 OHMS THE WEEK ENDING (B)(6) 2012 .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS WITH EXIT BLOCK. DURING THE REVISION, OVERSENSING WAS NOTED DURING MANIPULATION OF THE LEAD. THE PACE/SENSE PORTION WAS CAPPED AND REPLACED. THE HIGH VOLTAGE PORTION OF 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
    259751 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R D364VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR