BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3862274 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06994
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. CONCOMITANT MEDICAL PRODUCTS: DTBA1D4, ICD, (B)(6) 2014; 6725, ADAPTOR, (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACING IMPEDANCE. A CONNECTION ISSUE WAS SUSPECTED. A SECOND PROCEDURE WAS NEEDED, THE POCKET WAS OPENED AND THE RV LEAD WAS INSERTED FURTHER INTO THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE IMPEDANCE NORMALIZED. THE LEAD AND DEVICE REMAIN 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
    342465 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 419488 LEAD