BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2531180 · Received April 12, 2012

    Report

    Report Number
    2649622-2012-04355
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY FOR (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SAVE TO DISK REVIEW FOUND LEAD INTEGRITY ALERT TRIGGERED WITH PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. THERE WAS OVERSENSING WITH LFP HIGH RATE-NS LESS THAN EQUAL TO 217 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2011 AND (B)(6) 2012. ALSO, INTERFERENCE/NOISE WITH VENTRICULAR SHORT INTERVAL COUNT (V-SIC) EQUALING 11.4 COUNTS AVG/DAY, IN 16.86 DAYS, BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE ALERT TRIGGERED AGAIN FOR SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA. ALSO, IT WAS REPORTED THE LEAD IMPEDANCE HAD BEEN STABLE UNTIL THERE WAS A SWING RANGING FROM 665-1311 OHMS AND HAS SINCE STABILIZED BETWEEN 760-970 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD HAVING AN ELEVATED SENSING INTEGRITY COUNT AND HIGH RATE NON-SUSTAINED TACHYCARDIA. THE RV LEAD REMAINS 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
    1 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB