BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II DR

    MDR report key: 1921407 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05757
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATED INTERFERENCE/NOISE AND HIGH RESISTANCE/IMPEDANCE. ELEVATED SHORT INTEGRITY COUNTS (SIC) TOTALLING 1163 ARE OBSERVED BEGINNING FROM THE IMPLANT DATE OF (B)(6) 2010. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM. A SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT IS OBSERVED ON (B)(6) 2010, THE IMPLANT DATE, FOR ATRIAL PACE LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INQUIRY WAS MADE REGARDING THE REASON FOR THE SENSING INTEGRITY COUNT VALUE AND QUESTIONING IF THE HIGH COUNT COULD INDICATE A FRACTURED LEAD. THE DEVICE REMAINS 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 VIRTUOSO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 1488 COMPETITIVE IMPLANTABLE PACING LEAD| 0154 COMPETITIVE IMPLANTABLE TACHY LEAD