BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2964540 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02065
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4196 IMPLANTABLE PACING LEAD (B)(6) 2011; 5076 IMPLANTABLE PACING LEAD (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT PRODUCT ANALYSIS FOUND THAT THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUDDEN RISE IN AND HIGH THRESHOLD MEASUREMENTS AND THERE WAS INTERMITTENT CAPTURE AT HIGH OUTPUT. IT WAS ALSO REPORTED THAT THE R WAVES HAD SIGNIFICANTLY DECREASED AND WERE MEASURING LOW. REPROGRAMMING AND DEFIBRILLATION THRESHOLD TESTING WERE PERFORMED AND THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE LEAD WAS UNDERSENSING. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68515 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR