BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3992706 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09715
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    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

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    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: (B)(4) IPG IMPLANTED: 2011 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER A FAINTING EPISODE WITH A VERY LOW HEART RATE. THE DEVICE WAS CHECKED AND IT WAS DETERMINED A LEAD ALERT HAD OCCURRED. THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND HIGH PACING IMPEDANCE VALUES INDICATIVE OF A POSSIBLE LEAD FRACTURE. THE LEAD WAS REMOVED AND REPLACED. IT WAS NOTED DURING THE EXPLANT PROCEDURE, THE DISTAL PORTION OF THE LEAD WAS NOT ABLE TO BE RETRIEVED AFTER IT BROKE BY LASER EXTRACTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471317 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694465

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| L| R 5076-52 LEAD