BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 2051158 · Received April 12, 2011

    Report

    Report Number
    6000023-2011-00010
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 15 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=190 MS AVERAGE V-CYCLE BETWEEN (B)(4)-2010 12:05:28 AND (B)(4)-2010 20:35:20. VENTRICULAR SHORT INTERVAL COUNT V-SIC=14.7 COUNTS AVG/DAY, IN 184.2 DAYS, BETWEEN (B)(4)-2010 11:30:05 AND (B)(4)-2011 16:29:16.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SHORT V-V INTERVALS, WHICH COULD INDICATE OVERSENSING. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, B.V. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB