BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3860046 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05602
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 8, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO PULLING/STRETCHING/OVERSTRESS. CONCOMITANT MEDICAL PRODUCTS: AV5076-52 LEAD IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY WARNING OCCURRED, AND THE RIGHT VENTRICULAR (RV) LEAD WAS CONFIRMED FRACTURED. THE PATIENT RECEIVED INAPPROPRIATE THERAPY, AND EXPERIENCED SYMPTOMS OF SYNCOPE. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340238 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R D274DRG ICD