BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE

    MDR report key: 1874890 · Received October 19, 2010

    Report

    Report Number
    2182208-2010-00833
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 8, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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 ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR SHORT INTERVAL COUNT V-SIC=23 COUNTS ON (B)(6) 2010 IN THE TIMEFRAME BETWEEN 14:38:59 AND 18:05:39.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD NOISE AFTER THE SHOCK. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD NOISE AFTER THE SHOCK. THE LEAD IS STILL IN USE. 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 80 YR Other 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB