BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2790175 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05586
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO THE PATIENT ALERT AND INCREASED THRESHOLDS WHICH WAS NOTED ON THE RIGHT VENTRICULAR CHANNEL UPON DEVICE INTERROGATION. IT WAS ALSO REPORTED THAT A SECONDARY INTERROGATION REVEALED HIGH IMPEDANCE AND NO CAPTURE AT FULL OUTPUT POSSIBLE DUE TO A SETSCREW PROBLEM WITH THE DEVICE. THEREFORE THE VENTRICULAR LEAD WAS RESET IN THE DEVICE HEADER. THE DEVICE AND VENTRICULAR LEAD 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
    1 PROTECTA XT CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D314TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD