BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 2122341 · Received June 13, 2011

    Report

    Report Number
    6000094-2011-01272
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. SENSING - INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC=5.3 COUNTS AVG/DAY, IN 8.09 DAYS, BETWEEN (B)(6) 2010 10:36:32 AND (B)(6) 2010 12:45:28.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS OVERSENSING THE T-WAVES AND THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D234VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening| O