BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2905704 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00393
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    November 24, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (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 PRIMARY CAUSE OF DEATH PER THE CERTIFICATE OF DEATH WAS VENTRICULAR FIBRILLATION DUE TO DYSRHYTHMIA. (B)(4). ADD'L DEVICES: (B)(4) IMPLANTABLE PACING LEAD, (B)(6) 2012, (B)(4) IMPLANTABLE TACHY LEAD, (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT 'DIED SUDDENLY' AT HOME APPROXIMATELY ONE MONTH POST THE DEVICE SYSTEM IMPLANT. THE MANUFACTURER'S REPRESENTATIVE RECEIVED THE DEVICE SYSTEM, WITH PARTIAL PIECES OF THE LEADS, FROM THE PHYSICIAN AFTER BEING EXPLANTED BY THE FUNERAL HOME. THE FAMILY ASKED THAT THE DEVICE BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AS THE FAMILY WAS CONCERNED THE DEVICE 'MALFUNCTIONED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11839 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 00052 YR Death (B)(4) IMPLANTABLE PACING LEAD