BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1922633 · Received December 13, 2010

    Report

    Report Number
    6000023-2010-00026
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 14, 2009
    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
    IT
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD LOW IMPEDANCE WHICH TRIGGERED THE PATIENT ALERT. THE LEAD IMPEDANCE HAD BEEN DECREASING FOR THE PAST YEAR. THE LEAD WAS 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 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, B.V. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R