BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE

    MDR report key: 1991417 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00148
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. WEEKLY MINIMUM HIGH VOLTAGE MEASUREMENT LOG DATA SHOWS MIN HV-COIL IMPEDANCE OVER THE RANGE 16.88 OHMS MINIMUM TO 19.8 OHMS BETWEEN (B)(6) 2009 AND (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE QUESTIONED IF THE RIGHT VENTRICULAR (RV) LEAD HAD ANY INDICATIONS OF A LEAD INSULATION BREACH. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE QUESTIONED IF THE RIGHT VENTRICULAR (RV) LEAD HAD ANY INDICATIONS OF A LEAD INSULATION BREACH. THE LEAD IS STILL IN USE. 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, INC. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 6933 IMPLANTABLE TACHY LEAD| 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD| 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB