BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964970 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01982
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    July 25, 2012
    Report Date
    February 22, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT 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 WAS RECORDED ON (B)(6) 2012. OVERSENSING WAS SEEN. THERE WERE TWO EPISODES LABELED LEAD FAILURE PREDICTOR AND ARE IDENTIFIED IN THE EPISODES LIST.

    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 AN ALERT WAS TRIGGERED FOR OVERSENSING ON THE RIGHT VENTRICULAR LEAD. DUE TO THE PATIENT'S HEART HISTORY, THE PHYSICIAN DECIDED TO PLACE A NEW LEAD IN THE LEFT VENTRICLE AND USE IT FOR PACE/SENSE. THE EXISTING HIGH VOLT COIL OF THE RIGHT VENTRICULAR LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68863 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization| R D314VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR