BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 1922287 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05913
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2010 AT TIME STAMP 5:46:26 PM AND ON (B)(6) 2010 AT TIME STAMP 6:35:34 AM. HIGH V-SIC COUNTS ARE OBSERVED WITH 701 COUNTS ON THE LIFETIME COUNTER, MOST OF THESE COUNTS OCCURRING ON THE BEGINNING (B)(6) 2010. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM. MULTIPLE SHORT V-V SENSED EVENTS OF < 220 MS ARE OBSERVED ON (B)(6) 2010 THROUGH (B)(6) 2010. (15 EPISODES NST).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POSSIBLE HEADER/CONNECTION PROBLEM AND THERE WAS NOISE SEEN. IT WAS LATER REPORTED THAT THERE MAY BE A FRACTURE ON THE COMPETITOR LEAD OR A SET SCREW ISSUE. THE LEAD INTEGRITY ALERT WAS TRIGGERED AND THERE WAS EVIDENCE OF LOW IMEDANCE, NOISE AND OVERSENSING. WHEN THE POCKET WAS OPENED THEY COULD NOT REPRODUCE THE ISSUES BY TUGGING ON THE LEAD. IT WAS FURTHER REPORTED BY THE PATIENT THAT THE DEVICE ONLY LASTED ONE YEAR. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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 73 YR Hospitalization| R 7070 COMPETITOR IMPLANTABLE TACHY LEAD