BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990034 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08841
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: 5076-52 LEAD IMPLANTED 2006-(B)(6); 419688 LEAD IMPLANTED 2013-(B)(6); DTBA1D1 ICD IMPLANTED 2013-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPL ANTED AND REPLACED. DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) AND RIGHT ATRIAL (RA) LEADS BOTH BECAME DISLODGED. THE RA LEAD INSULATION WAS ALSO DAMAGED. BOTH THE RA AND LV LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465112 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 694965 LEAD