BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991830 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02571
    Event Type
    Injury
    Date Received
    February 15, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD IMPEDANCE ON (B)(6) 2010 09:00:16. DAILY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR VENTRICULAR PACE BI IMPEDANCE=988 TO 4047 OHMS PEAK BETWEEN (B)(6) 2010 AND (B)(6) 2010. 2 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) =210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2010 16:53:13 AND (B)(6) 2010 10:34:08. 1 - VF=200 MS ON (B)(6) 2010 13:46:16. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010 09:00:16. WEEKLY LOG DATA IN SAVE TO DISK FILE (B)(4) SHOWS SIX WEEKS OF MISSING IMPEDANCE MEASUREMENT DATA FOR PACE, AND DEFIB IMPEDANCE BETWEEN (B)(6) 2010 AND (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED, AND THE LEAD EXHIBITED HIGH IMPEDANCE AND OVERSENSING. THE LEAD WAS CHECKED USING THE ANALYZER, AND NO ISSUES WERE FOUND. A BACKUP PACEMAKER WAS IMPLANTED, AND THE 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
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD