BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955596 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01488
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    February 26, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #US FDA MDR. THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - US FDA MDR WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE NO ANOMALIES FOUND FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. UPON INTERROGATION, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED T-WAVE OVERSENSING. IT WAS ALSO DETERMINED THE RWAVES HAD DECREASED SUGGESTING A POTENTIAL DISLODGEMENT OR MIGRATION OF THE LEAD. THE RV LEAD WAS REPOSITIONED, AND DURING THE PROCEDURE, IT WAS FOUND THAT THE PATIENT HAD AN INFECTION. THE RV LEAD AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WERE REMOVED. SEVERAL WEEKS LATER, A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57916 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC