BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3152408 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06824
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    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 RIGHT VENTRICULAR (RV) IMPLANTABLE TACHY LEAD WAS EXPERIENCING SYMPTOMS INDICATING A POSSIBLE LEAD FRACTURE. THE SYMPTOMS INCLUDE INTERMITTENT HIGH IMPEDANCE, INCREASED SIC COUNT, SHORT AND FAST NST AND VF EPISODES, AND ARTIFACT ON THE LEAD. THIS ISSUE CAUSED THE DELIVERY OF MULTIPLE INAPPROPRIATE SHOCKS. THE LEAD WAS REPROGRAMMED WITH THE THERAPIES OFF AND DETECTION SET TO MONITOR, WHICH RESOLVED THE ARTIFACT ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252716 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| L| R