BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3162327 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10136
    Event Type
    Death
    Date Received
    June 11, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    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 DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO ADDITIONAL INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 694758 IMPLANTABLE TACHY LEAD: IMPLANTED: (B)(6) 2009. 638BL30 ANNULOPLASTY BAND: IMPLANTED (B)(6) 2012. 1156T COMPETITOR IMPLANTABLE PACING LEAD: IMPLANTED (B)(6) 2009. 1699TC COMPETITOR IMPLANTABLE PACING LEAD: IMPLANTED (B)(6) 2009.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH INFORMATION INDICATING THE PATIENT IS DECEASED. NO ADDITIONAL INFORMATION WAS PROVIDED. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS AFTER ICD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263340 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death