BEUDAMED
    FDA Adverse Event Summary report: N

    ENTRUST AT

    MDR report key: 1862873 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05040
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED OVERSENSING". 1 - VF EPISODE WITH AN AVERAGE V.CYCLE=180 MS ON (B)(6), 2010 AT 17:04:04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR GASTROINTESTINAL BLEEDING. THE PATIENT HAD ATRIAL FLUTTER WITH A RAPID VENTRICULAR RATE. PERIODS OF ATRIAL UNDERSENSING WERE REPORTED AND THE DOCTOR INDICATED THE ICD ACCELERATED THE RHYTHM FOR ONE EPISODE AND IN ANOTHER EPISODE THE ATRIAL ATP WAS TURNED OFF FOR ACCELERATING THE VENTRICULAR RHYTHM. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR GASTROINTESTINAL BLEEDING. THE PATIENT HAD ATRIAL FLUTTER WITH A RAPID VENTRICULAR RATE. PERIODS OF ATRIAL UNDERSENSING WERE REPORTED AND THE DOCTOR INDICATED THE ICD ACCELERATED THE RHYTHM FOR ONE EPISODE AND IN ANOTHER EPISODE THE ATRIAL ATP WAS OFF FOR ACCELERATING THE VENTRICULAR RHYTHM. THE DEVICE 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 ENTRUST AT ASKU LWS MEDTRONIC MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5554 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD