BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA VR

    MDR report key: 1989030 · Received February 14, 2011

    Report

    Report Number
    6000144-2011-00512
    Event Type
    Malfunction
    Date Received
    February 14, 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
    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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ALERT - LEAD INTEGRITY ALERT TRIGGERED 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010 17:55:20. SENSING - OVERSENSING 3 - VENTRICULAR NST=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 IN THE TIMEFRAME BETWEEN 17:44:53 AND 20:42:30; 9 - VF<=210 MS BETWEEN (B)(6) 2010 15:25:33 AND (B)(6) 2010 00:48:26.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED AFTER THE PATIENT HAD EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILATION. THE LEAD REMAINS 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other (B)(4) IMPLANTABLE TACHY LEAD