BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993387 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09339
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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: DDBB1D4, ICD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD ACUTELY DISLODGED AND HAD DROPPED INTO THE RIGHT VENTRICLE. THE RA LEAD WAS REVISED AND REMAINS IN USE. IN ADDITION, DURING THE REVISION PROCEDURE, THE PHYSICIAN INADVERTENTLY CUT THE RIGHT VENTRICULAR (RV) LEAD TO THE DEGREE WHERE A "HEEN" OF FLUID WAS NOTICED IN THE OUTER LAYER OF INSULATION. THE PHYSICIAN OPTED TO PLACE MEDICAL ADHESIVE OVER THE CUT AND APPLY A SUTURE SLEEVE. THE RV LEAD 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
    469923 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 507652 LEAD