BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1072358 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00360
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 30, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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: NO ANOMALIES FOUND. NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. IT WAS REPORTED THAT THERE WAS A SUBSTANTIAL DROP IN LEAD IMPEDANCE, SO THE LEAD WAS REPLACED. WHEN THE NEW LEAD WAS ATTACHED TO THE DEVICE, OVERSENSING/NOISE ON THE VENTRICULAR PACE/SENSE CHANNEL OCCURRED. ATTEMPTS WERE MADE TO DISCONNECT AND RECONNECT THE LEAD, BUT IT COULD NOT BE RESOLVED. THEREFORE, THE DEVICE WAS ALSO REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED OVERSENSING NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUBSTANTIAL DROP IN LEAD IMPEDANCE, SO THE LEAD WAS REPLACED. WHEN THE NEW LEAD WAS ATTACHED TO THE DEVICE, OVERSENSING/NOISE ON THE VENTRICULAR PACE/SENSE CHANNEL OCCURRED. ATTEMPTS WERE MADE TO DISCONNECT AND RECONNECT THE LEAD, BUT IT COULD NOT BE RESOLVED. THEREFORE, THE DEVICE WAS ALSO REPLACED. NO 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 Required Intervention 5076 IMPLANTABLE PACING LEAD