BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153232 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05892
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2011; 4196 IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING AN INAPPROPRIATE SHOCK DUE TO NOISE ON THE RIGHT VENTRICULAR LEAD. THE SENSING ON THE LEAD WAS REPROGRAMMED. IT WAS ALSO NOTED THE LEAD ALERT TRIGGERED ONE DAY PRIOR DUE TO OVERSENSING. A FRACTURE OF THE PACE/SENSE PORTION OF THE LEAD WAS SUSPECTED. A NEW LEAD WAS PLACED A FEW DAYS LATER FOR PACING AND SENSING AND THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS 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
    254983 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| L| R D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC