BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3861147 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11259
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTS: MODEL: 6935M62, LEAD; IMPLANT: (B)(6) 2013; MODEL: ADSR01 IPG, IMPLANT: (B)(6) 2013; MODEL: 5076-58, IMPLANTABLE PACING LEAD; IMPLANT: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITHHELD THERAPY DUE TO THE MORPHOLOGY DISCRIMINATOR NOT ACCURATELY DETECTING VENTRICULAR TACHYCARDIA (VT), REQUIRING THE PATIENT TO BE EXTERNALLY CARDIOVERTED. PROGRAMMING INTERVENTION WAS DONE TO TURN OFF THE DISCRIMINATOR. 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
    340089 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| L| R 407645 LEAD