BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2053516 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01627
    Event Type
    Malfunction
    Date Received
    April 13, 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
    MN, 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. 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. 1 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) =190 MS AVERAGE V-CYCLE ON (B)(6) 2010 10:21:41.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD OVER SENSING WITH ELEVATED SHORT INTERVAL COUNTER (SIC) COUNTS AND AN EPISODE OF T-WAVE OVERSENSING. THE DEVICE 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 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other UNK COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD