BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE SVC/CS

    MDR report key: 2124007 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00726
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S5
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 FOR (B)(4): THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DEFIBRILLATION CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DEFIBRILLATION CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED HIGH RESISTANCE/IMPEDANCE. THREE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED BETWEEN (B)(6) 2011 AND (B)(6) 2011. DAILY HIGH VOLTAGE LEAD IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE AND AN ABRUPT INCREASE FOR SUPERIOR VENA CAVA DEFIB OF 50 TO 254 OHMS PEAK, BETWEEN (B)(6) 2011 AND (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD SVC (SUPERIOR VENA CAVA) COIL HAD IMPEDANCE GREATER THAN 200 OHMS AND THAT THE LEAD WAS BROKEN. THE LEAD WAS EXPLANTED AND 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 SVC/CS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6937 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 6935 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB