BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1925360 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06296
    Event Type
    Injury
    Date Received
    December 14, 2010
    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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED HIGH RESISTANCE/IMPEDANCE. AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE MEASUREMENT INITIATED A PATIENT ALERT (B)(6) 2010. RV PACE LEAD IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 375 OHMS THE WEEK OF (B)(6) 2010 TO A HIGH OF 1904 OHMS THE WEEK OF (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE IN IMPEDANCE ON THE RIGHT VENTRICULAR LEAD (COMPETITOR). THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE IN IMPEDANCE AND A HIGH/UNSTABLE/UNMEASUREABLE THRESHOLD ON THE RIGHT VENTRICULAR LEAD (COMPETITOR). THE DEVICE WAS EXTRACTED ALONG WITH THE LEAD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD