BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3062234 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05099
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINICAL AND IT WAS FOUND THERE HAD BEEN AN INAPPROPRIATE SHOCK FROM THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD HIGHLY VARIABLE AND OUT OF RANGE IMPEDANCE WHICH HAD RISEN TO 1472 OHMS. THE RV LEAD ALSO HAD A HIGH NUMBER OF SHORT INTERVAL COUNTS AND NUMEROUS NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THE RV LEAD DETECTIONS AND PACING WERE REPROGRAMMED OFF AND IT WAS ELECTED TO NOT SURGICALLY REVISE THE SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162382 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R