BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE SVC/CS

    MDR report key: 1990461 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00126
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    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 SUB-THRESHOLD LEAD IMPEDANCE MIN SVC IN THE RANGE 74 TO 85 OHMS AND MIN HVB IN THE RANGE 47 TO 56 OHMS BETWEEN (B)(6) 2009 AND (B)(6) 2010. ONE VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) =190 MS AVERAGE V-CYCLE ON (B)(6) 2010 18:26:44. ELEVEN EPISODE RECORDS IN SAVE TO DISK SHOW HVZ= "<20" BETWEEN E22 AND E26.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE AND THE DEVICE WAS NOT DELIVERING THE FULL ENERGY ON MULTIPLE THERAPY EVENTS. THE PROBLEM COULD NOT BE REPLICATED LATER WITH TESTING, AND NO VISIBLE INSULATION BREACHES WERE NOTED ON THE VISIBLE PORTION OF EITHER LEAD IN THE POCKET WHILE THE POCKET WAS OPEN. THE LEADS WERE CAPPED 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. 6933 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB