BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951883 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00256
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 6, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO T-WAVE OVERSENSING. THE POLARITY WAS REPROGRAMMED AND THE RV LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56757 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

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