BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3050927 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04807
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY CROSSING THE RIGHT VENTRICULAR (RV) LEAD TO THE TRICUSPID VALUE DUE TO PATIENT'S ANATOMY. ONCE THE LEAD WAS IN THE APEX, IT HAD HIGH IMPEDANCE AND WAS UNABLE TO CAPTURE. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152718 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR