BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2452330 · Received February 15, 2012

    Report

    Report Number
    2649622-2012-01003
    Event Type
    Injury
    Date Received
    February 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. LEAD INTEGRITY ALERT TRIGGERED. PATIENT ALERT FOR LEAD FAILURE PREDICTOR (LFP) ON (B)(6) 2011 03:00:07. OVERSENSING WAS NOTED. FOR HIGH RATE NON-SUSTAINED EPISODE LESS THAN OR EQUAL TO 150 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 04:17:27 AND 08:06:56. INTERFERENCE/NOISE WAS NOTED. VENTRICULAR SHORT INTERVAL COUNT (V-SIC) OF 11 COUNTS, IN 0.53 DAY, BETWEEN (B)(6) 2011. HIGH RESISTANCE/IMPEDANCE WAS NOTED. PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 03:00:07. PROGRAMMER DATA FOR S2D FILE (B)(4) SHOWS A PATIENT ALERT FOR RV BIPOLAR LEAD IMPEDANCE 1368 OHMS ON (B)(6) 2011 03:00:07.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO LEAD INTEGRITY ALERT. THE LEAD HAD NOISE ON RIGHT VENTRICULAR CHANNEL, UNSTABLE PACING IMPEDANCE, OVERSENSING, AND HIGH LEAD IMPEDANCE. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D354DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB