BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2130631 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03358
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 24, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. A LEAD INTEGRITY ALERT TRIGGERED AS A LEAD FAILURE PREDICTOR ON (B)(6) 2011 02:01:53. THERE WERE EPISODES OF VENTRICULAR NON-SUSTAINED TACHYCARDIA RECORDED ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 02:01:53 AND 04:40:42. INTERFERENCE/NOISE WAS REPORTED. VENTRICULAR SHORT INTERVAL COUNT V-SIC=74 COUNTS, IN 0.18 DAY, ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 00:21:02 AND 04:41:37.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED INAPPROPRIATELY DUE TO SENSING INTEGRITY COUNTS AND NONSUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THE PATIENT RECEIVED AN APPROPRIATE SHOCK. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| O 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD