BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT VR

    MDR report key: 2810151 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01749
    Event Type
    Death
    Date Received
    October 31, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES 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. ALL REASONABLE CONTACTS HAVE BEEN FOLLOWED UP WITH AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. ANY FURTHER INFORMATION THAT GETS MADE AVAILABLE WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE AND NO FURTHER CONTACTS ARE KNOWN. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN RECEIVED IN REGARDS TO THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE AND NO FURTHER CONTACTS ARE KNOWN. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN RECEIVED IN REGARDS TO THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death