BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3160469 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07987
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 4968 IMPLANTABLE PACING LEAD 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A JUMP IN THRESHOLDS, AN INCREASE IN IMPEDANCE, HIGH IMPEDANCE AND T-WAVE OVERSENSING (TWOS). DETECTIONS WERE TURNED OFF, BUT THERE WAS STILL NOISE, OVERSENSING, AND HIGH THRESHOLDS. IT WAS DETERMINED THAT THE RV LEAD HAD DISLODGED. THE LEAD WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259735 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR