BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2203257 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04167
    Event Type
    Injury
    Date Received
    August 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
    PA, 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 DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DEFIBRILLATION CONDUCTOR WAS DISTORTED AND THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION HAD A COSMETIC DEPRESSION. BLOOD WAS PRESENT IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD. VISUAL ANALYSIS REVEALED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD OVERSENSING AND T-WAVE UNDERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED TO GIVE DIFFERENT PROGRAMMING OPTIONS. 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 53 YR Hospitalization| R