BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3862308 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06966
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 MEDICAL PRODUCTS: DTBA1D4 ICD, (B)(6) 2013; 407652 LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POST PACE T-WAVE OVERSENSING (TWOS), DOUBLE COUNTING OF R-WAVES, AND OVER 300,000 SHORT INTERVAL COUNTS (SIC)'S. THE PHYSICIAN QUESTIONED IF THIS INDICATED A POSSIBLE FRACTURE. THE SENSITIVITY WAS REPROGRAMMED AND THE DOUBLE COUNTING AND OVERSENSING WERE RESOLVED. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338386 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention 429688