BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3152922 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05759
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED WITH HIGH IMPEDANCE, HIGH AND UNSTABLE THRESHOLDS, AND OVERSENSING OR NOISE. A LEAD FRACTURE OR CONNECTION ISSUE WAS SUSPECTED. THE PACING PORTION OF THE LEAD WAS CAPPED AND REPLACED, BUT THE SUPERIOR VENA CAVA (SVC) PORTION REMAINS IN USE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND WAS REPLACED DUE TO THE SUSPECTED CONNECTION ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258041 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694775

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R