BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862364 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06953
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 2, 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. CONCOMITANT MEDICAL PRODUCTS: D224DRG ICD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED WITHIN A WEEK OF A DEVICE CHANGE OUT DUE TO HIGH PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS DETERMINED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS RESEATED IN THE HEADER AND THE SET SCREW WAS RESET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338477 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 407652