BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812351 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15926
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE. 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 02:15:02. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR MAX RV PACE = 456 TO 1616 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012, THEN RETURNING TO 600 OHMS ON (B)(6) 2012. IMPEDANCE - LOW RESISTANCE/IMPEDANCE. 9 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2009 02:15:03 AND (B)(6) 2012 02:15:02. PROGRAMMER S2D DATA FILE (B)(4) SHOWS 9- ALERT EVENTS FOR "A BIPOLAR LEAD IMPEDANCE < 200 OHMS", BETWEEN (B)(6) 2009 02:15:03 AND (B)(6) 2012 02:15:02. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED PROGRAMMER DATA SHOWS 1 - RV - LEAD INTEGRITY ALERT ON (B)(6) 2012 23:37:36.1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 23:37:36. SENSING - OVERSENSING 14 - VENTRICULAR NST<=210 MS BETWEEN (B)(6) 2012 13:43:21 AND (B)(6) 2012 11:07:25. SENSING - INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC=107.3 COUNTS AVG/DAY, IN 45.23 DAYS, BETWEEN (B)(6) 2012 06:11:02 AND (B)(6) 2012 11:42:25.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEPSIS. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO SHORT NONPHYSIOLOGIC INTERVALS ON THE RIGHT VENTRICLE (RV) LEAD. OVERSENSING AND A SPIKE IN IMPEDANCE WAS ALSO NOTED ON THE RV LEAD AND A LEAD FRACTURE WAS SUSPECTED. THE RIGHT ATRIAL LEAD HAD CHRONICALLY LOW IMPEDANCE WITH VERY RECENT DIMINISHED ATRIAL SENSING AMPLITIDES. THE LEADS REMAIN IN USE BUT WILL BE REPLACED ONCE THE SEPSIS HAS BEEN RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB