BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2965020 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01891
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    EVENT SUMMARY: (B)(4) -THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. A LEAD INTEGRITY ALERT TRIGGERED ON (B)(6) 2012 DUE TO MEETING THE REQUIRED NON-SUSTAINED TACHYCARDIA AND ABNORMAL IMPEDANCE CONDITIONS. AN OUT OF THRESHOLD SUBTHRESHOLD LEAD IMPEDANCE IS RECORDED ON (B)(6) 2012. THE LOW VOLTAGE PERMANENT PACE IMPEDANCE CLIMBS FROM A BASELINE OF 703 OHMS THE WEEK ENDING 2011-12-18 TO AN APPROXIMATE BASELINE OF 1000 OHM PRIOR TO EXPLANT. THE BULK OF THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTS ((B)(4)) OCCUR BEGINNING (B)(6) 2012. THERE WERE FIVE EPISODES OF VENTRICULAR FIBRILLATION AND 15 EPISODES OF NON-SUSTAINED TACHYCARDIA OF LESS THAN 220 MILLISECONDS ARE RECORDED BETWEEN THE DATES OF (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE AND HIGH PACING IMPEDANCE. THE LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68376 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR