BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4160088 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12030
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD BECAME DISLODGED. IT WAS DETERMINED THAT THE PATIENT EXHIBITED SYMPTOMS OF TWIDDLER'S SYNDROME. IN ADDITION, THE RETRACTION OF THE LV LEAD CAUSED THE PARTIAL DISLOCATION OF THE RIGHT VENTRICULAR (RV) LEAD RESULTING IN LOW SENSING OF THE RV LEAD. THE LV LEAD AND RV LEAD WERE EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637606 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 419688 LEAD