BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993490 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09272
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 31, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCTS: 507645 IMPLANTABLE PACING LEAD IMPLANTED 2005 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON A LEAD WAS UNDEFINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPLACEMENT RV LEAD SHOWED INCREASED PACING THRESHOLDS AND REDUCED R WAVES. THE RV REPLACEMENT LEAD WAS REPOSITIONED AND REMAINS 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
    466846 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R (B)(4) ICD