BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1926292 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14267
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010 21:00:04. DAILY PACE IMPEDANCE TREND DATA SHOWS VENTRICULAR PACE BI IMPEDANCE VARYING, FROM VENTRICULAR PACE BI IMPEDANCE= 912 TO 285 OHMS MINIMUM BETWEEN (B)(6) 2010 AND (B)(6) 2010, THEN RETURNING TO 950 OHMS ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RECENTLY IMPLANTED LEAD HAD TRIPPED AN ALERT, HAD IMPEDANCE FLUCTUATIONS AND THAT THE PACING THRESHOLDS HAD INCREASED. THE LEAD IS STILL IN USE AND BEING MONITORED. THERE WERE NO PATIENT COMPLICATIONS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD