BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4162882 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12552
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THERE WERE NO ANOMALIES OBSERVED REGARDING THE RETURNED LEAD PROXIMAL SEGMENT. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. THE FULL LEAD WAS NOT RETURNED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076-52, LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED RISING THRESHOLDS. IT WAS ALSO REPORTED THAT THERE WAS A STEADY RISE IN IMPEDANCE AND THE IMPEDANCE STAYED GREATER THAN 2500 OHMS. THE LEAD WAS CAPPED 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
    640465 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R D314DRG ICD