BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990980 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08370
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNTER (SIC). 30 OF 60 LIFETIME VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) ARE RECORDED BEGINNING (B)(4) 2014. LIA TRIGGERED ON (B)(4) 2014 DUE TO MEETING THE REQUIREMENTS FOR NON-SUSTAINED TACHYCARDIA (NST) AND V-SIC. MAX LV PACE IMPEDANCE RISES FROM 704 OHM THE WEEK ENDING 08 MAR 2013 TO > 1800 OHM THE WEEK ENDING 17 JAN 2014. THERE ARE 2 NST EVENTS OF <(><<)> 220 MS V-V CYCLE RECORDED ON (B)(4) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE LEAD WAS RETURNED WITH AN EXTRINSIC INNER/OUTER INSULATION BREACH/CUT. BLOOD INGRESS WAS NOT OBSERVED AND IT IS LIKELY THE CUT OCCURRED DURING EXPLANT. THERE WERE NO OTHER ANOMALIES OBSERVED. A CONDUCTOR FRACTURE WAS NOT OBSERVED AND ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. (B)(4).

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. IT WAS ALSO REPORTED THAT THERE WAS A ABNORMAL, PROGRESSIVE DETERIORATION IN THE R-WAVES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIPPED LEAD INTEGRITY ALERT (LIA) FOR EPISODES OF SHORT INTERVAL COUNTS (SIC), HIGH IMPEDANCE, AND NOISE. IT WAS NOTED DURING THE REVISION THAT THERE WAS A NOTICEABLE CONDUCTOR FRACTURE FOUND BY THE SUTURE SLEEVE. THE LEAD WAS EXPLANTED AND 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
    469765 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R DVBB1D4 ICD