BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3153338 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08909
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 429678 IMPLANTABLE PACING LEAD, (B)(6) 2013; 2088TC COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN ONE DAY OF IMPLANT THERE WAS OVERSENSING AND NOISE. UNDER FLUOROSCOPY, THE LEAD APPEARED KINKED DISTAL TO THE SUTURE SLEEVE. ULTIMATELY, THE OVERSENSING AND NOISE WERE DETERMINED TO BE DUE TO A LOOSE SETSCREW. THE LEAD WAS EXPLANTED AND REPLACED, AND 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
    258008 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR (B)(4) IMPLANTABLE TACHY LEAD