BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1984885 · Received February 11, 2011

    Report

    Report Number
    2647346-2011-00100
    Event Type
    Injury
    Date Received
    February 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "IMPEDANCE/RESISTANCE DECREASE". A DECREASE IN IMPEDANCE IS OBSERVED ON THE SVC LEAD IMPEDANCE TREND DURING THE WEEK OF (B)(6) 2010 TO 56 OHMS. THE IMPEDANCE RECOVERS SLIGHTLY TO A HIGH OF 92 OHMS ON (B)(6) 2010. ANALYSIS ALSO REVEALED "INTERFERENCE/NOISE". HIGH V-SIC COUNTS ARE OBSERVED ON (B)(6) 2010, 300 COUNTS OCCURRING ON THAT DAY. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERSENSING, OVERSENSING, AND INTERMITTENT LOSS OF CAPTURE WAS OBSERVED FOR THE RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED. ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW UP WITH THE SALES REPRESENTAIVE INDICATED THAT THERE WAS DEVICE UNDERSENSING AND/OR OVERSENSING. THE PHYSICIAN WAS UNCLEAR IF THE LEAD HAD FRACTURED, AND DECIDED TO REPLACE THE LEAD DUE TO THE AGE/HISTORY OF THE LEAD. THE DEVICE WAS ALSO 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 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 6933 IMPLANTABLE PACING LEAD