BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2952133 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00429
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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). EVALUATION SUMMARY: (B)(4): REVIEW OF PERFORMANCE DATA FOUND OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS ABANDONED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD), WHICH WAS CONNECTED TO THIS LEAD, GENERATED AN AUDIBLE "PATIENT ALERT" FOR LEAD INTEGRITY (LIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56794 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE CRT-D