BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 2573611 · Received May 14, 2012

    Report

    Report Number
    2647346-2012-00340
    Event Type
    Death
    Date Received
    May 14, 2012
    Date of Event
    June 24, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. THE PRODUCTS ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. A CAUSE OF DEATH WILL NOT BE RECEIVED. EVALUATION SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD COSMETIC DEPRESSION. A VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD COSMETIC DEPRESSION. A VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) - THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PRODUCTS ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. A CAUSE OF DEATH WILL NOT BE RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PRODUCTS ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. A CAUSE OF DEATH WILL NOT BE RECEIVED. EVALUATION SUMMARY: (B)(4)-THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD COSMETIC DEPRESSION. A VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4)-THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD COSMETIC DEPRESSION. A VISUAL ANALYSIS WAS PERFORMED ONLY.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY (B)(6) MONTHS POST THE DEVICE SYSTEM IMPLANT.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST THE DEVICE SYSTEM IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death