BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2203681 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11722
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 REVIEWED AND REVEALED LEAD INTEGRITY ALERT TRIGGERED. THERE WAS ALSO A PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011. HIGH RESISTANCE/IMPEDANCE, PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011. DAILY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR VENTRICULAR PACE BI IMPEDANCE EQUALS 437 TO 4047 OHMS PEAK BETWEEN (B)(6) 2011. IN ADDITION THERE WAS INTERFERENCE/NOISE, VENTRICULAR SHORT INTERVAL COUNT V-SIC EQUALS 31.2 COUNTS AVG/DAY, IN 2.76 DAYS, BETWEEN (B)(6) 2011.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT HAVING DIZZINESS AND HEARING A PATIENT ALERT. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD IMPEDANCE GREATER THAN 3000 OHMS, A LEAD WARNING AND NO CAPTURE AT 8 VOLTS AT 1.5 MILLISECOND. FOLLOW-UP INFORMATION FURTHER REPORTED THAT THE LEAD WAS NOT SENSING APPROPRIATELY. THE LEAD WAS CAPPED AND REPLACED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB