BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072197 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00235
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 7, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: TAV102567R NO ANOMALIES FOUND; PROXIMAL SEGMENT RETURNED AND ANALYZED. IT WAS REPORTED THE LEAD WAS REPLACED DUE TO OVERSENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED MECHANICAL TESTS PERFORMED VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS NO CONCLUSION CAN BE DRAWN OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REPLACED DUE TO OVERSENSING. NO 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, INC. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD| 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB