BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955533 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01386
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THERE WAS BODY TISSUE/FIBROTIC GROWTH ON THE DISTAL END OF THE ELECTRODE. THE DEFIBRILLATION SUPERIOR VENA CAVA COIL WAS PULLED/STRETCHED/OVERSTRESSED. VISUAL ANALYSIS REVEALED THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HIGH IMPEDANCE ALERT ON THE LEAD. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58858 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R