BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II VR

    MDR report key: 2052957 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01565
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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. 1- PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 09:00:04. DAILY HV-LEAD IMPEDANCE TREND DATA SHOWS SVC DEFIB=61 TO 254 OHMS MAX BETWEEN (B)(6) 2011 , THEN RETURNS TO 66 OHMS ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IMPEDANCE ALERT SOUNDED AND THAT THERE WAS NOISE. THE LEAD'S SVC (SUPERIOR VENA CAVA) COIL WAS TURNED OFF. IT WAS FURTHER REPORTED THAT THE ATP (ANTI-TACHYCARDIA PACING) AND SHOCKS REPORTED AS HAVING FOUR SHOCKS FAILED. FOLLOW UP INFORMATION WAS RECEIVED AND INDICATED THAT THE DEVICE MAY HAVE A LOOSE SET SCREW. THE PHYSICIAN INTENDS TO TEST THE PATIENT'S SYSTEM NON-INVASIVELY. 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD