BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2952495 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00609
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND THE RIGHT VENTRICULAR DEFIBRILLATION IMPEDANCES WERE HIGH AND OUT OF RANGE. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE (B)(4) 2012. DAILY PACE LEAD TREND DATA SHOWS AN INCREASE FOR DEFIBRILLATION ACTIVE CAN ON IMPEDANCE EQUAL TO 69 TO 101 OHMS RANGE BETWEEN (B)(4) 2012.

    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 PRODUCT: 5076 IMPLANTABLE PACING LEAD 2011 (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOTE MONITORING TRANSMISSION REPORT SHOWED THE RIGHT VENTRICULAR (RV) LEAD HAD A TREND OF FLUCTUATING RV DEFIBRILLATION COIL IMPEDANCES AND AN ALERT OCCURRED DUE TO IMPEDANCE GREATER THAN 100 OHMS. IT WAS NOTED THAT THE REST OF THE LEAD TRENDS LOOKED OKAY. THE PATIENT WAS GOING TO GO INTO THE CLINIC TO BE FURTHER EVALUATED. THE RV LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57137 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR