BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3181488 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10678
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    May 22, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED AND 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. PRODUCT ID: 6944-65, IMPLANTED: (B)(6) 2001; PRODUCT ID: 5076-52, IMPLANTED: (B)(6) 2013; PRODUCT ID: 429688, IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION REQUIRING THE IMPLANTABLE CARDIAC DEFIBRILLATION (ICD) SYSTEM TO BE REMOVED. DURING THE REMOVAL OF THE ICD SYSTEM THE PHYSICIAN REPORTED THE PATIENT DIED AND THAT THE LASER LEAD EXTRACTION MAY HAVE CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283303 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 00079 YR Death