BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992502 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09848
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER THE LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. A POSSIBLE FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468547 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R D284VRC, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR