BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811880 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17390
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR WAS FLEXED FRACTURED (IN-VIVO).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. IT WAS ALSO REPORTED THAT THE RV LEAD WAS OVERSENSING AND LEAD IMPEDANCE MEASUREMENTS VARIED FROM 400 OHMS TO GREATER THAN 2500 OHMS. THE PATIENT REPORTEDLY RECEIVED TWO INAPPROPRIATE SHOCKS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. IT WAS ALSO REPORTED THAT THE RV LEAD WAS OVERSENSING AND LEAD IMPEDANCE MEASUREMENTS VARIED FROM 400 OHMS TO GREATER THAN 2500 OHMS. THE PATIENT REPORTEDLY RECEIVED TWO INAPPROPRIATE SHOCKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB