BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3071689 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05230
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THERE WAS 1- PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2013, A LEAD INTEGRITY ALERT TRIGGERED, THERE WERE 13 - VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES <(><<)> = 215 MS ON (B)(6) 2013, 1 VF = 210 MS AVERAGE V-CYCLE ON (B)(6) 2013, 5-LFP HIGH RATE-NS <(><<)>= 195 MS AVERAGE V-CYCLE ON (B)(6) 2013, VENTRICULAR SHORT INTERVAL COUNT V-SIC=3684 COUNTS, IN 3.99 DAYS, BETWEEN (B)(6) 2013. ONE PATIENT ALERT FOR OUT OF TOLERANCE THRESHOLD LEAD IMPEDANCE ON (B)(6) 2013, A DAILY PACE LEAD TREND DATA SHOWS A SPIKE INCREASE FOR VENTRICULAR PACE BI IMPEDANCE = 361 TO 4047 OHMS PEAK BETWEEN (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP THE RIGHT VENTRICULAR (RV) LEADSHOWED OVERSENSING. POSSIBLE RV LEAD FRACTURE IS SUSPECTED. THE LEAD WAS EXPLANTED 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
    172619 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R