BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2448366 · Received February 13, 2012

    Report

    Report Number
    2649622-2012-00272
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 09:00:15 AND (B)(6) 2011 03:00:20. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS A GRADUAL INCREASE FOR MIN AND MAX VENTRICULAR PACE BI IMPEDANCE = 1054 TO 1520 OHMS PEAK BETWEEN (B)(6) 2010 AND (B)(6) 2011. SENSING - OVERSENSING: 1 - VENTRICULAR NST=190 MS (B)(6) 2011 21:43:59. 1 - VF=190 MS AVERAGE V-CYCLE ON (B)(6) 2011 09:24:13.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED OVERSENSING. THE PHYSICIAN ATTEMPTED POCKET MANIPULATION OTHER ISOMETRICS, BUT WAS UNABLE TO REPRODUCE THE OVERSENSING. THE PHYSICIAN INDICATED THAT THE LEAD IS MOST LIKELY FINE. THE 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 5568 IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB