BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3992399 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14828
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT MEDICAL PRODUCTS: 37714 PAIN STIM IPG, IMPLANTED: (B)(6) 2013; 1058T86 ST. JUDE LEAD, IMPLANTED: (B)(6) 2007; 4076 LEAD, IMPLANTED: (B)(6) 2007; 6949-58 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE "WENT OFF/SHOCKED". FOLLOW UP WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472503 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 00071 YR Life Threatening 39565-65 PAIN STIM LEAD