BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2209388 · Received August 12, 2011

    Report

    Report Number
    2649622-2011-11480
    Event Type
    Injury
    Date Received
    August 12, 2011
    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
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED OVERSENSING. 1 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE WHERE THE AVERAGE V-CYCLE WAS 210 MS OCCURRED ON (B)(6) 2011 15:31:47. 3 VENTRICULAR FIBRILLATION EPISODES WHERE THE AVERAGE V-CYCLE WAS 210 MS OCCURRED BETWEEN (B)(6) 2011 15:15:26 AND (B)(6) 2011 10:52:50. ANALYSIS ALSO REVEALED INTERFERENCE/NOISE AND A VENTRICULAR SHORT INTERVAL COUNT OF 16 COUNTS AVG/DAY, IN 63.75 DAYS, BETWEEN (B)(6) 2011 21:01:26 AND (B)(6) 2011 13:57:43.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS REPROGRAMMED AND 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R 5076 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB