BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2864902 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11426
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO, JUNCOS
    Product Code
    LWS
    PMA / PMN Number
    P890003/S181
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4). 5076 IMPLANTABLE PACING LEAD 2012 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE, NO CAPTURE, AND POOR SENSING DURING A ROUTINE CHECK. DURING THE PROCEDURE TO INVESTIGATE THE ISSUE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED FROM THE POCKET AND THE ATRIAL LEAD WAS TESTED THROUGH THE ANALYZER, VALUES WERE NORMAL. THE LEAD PIN WAS REINSERTED IN THE ATRIAL PORT AND THEN VALUES WERE WITHIN NORMAL RANGE. THE DEVICE AND LEAD REMAIN 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 DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO, JUNCOS D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD