BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 5101416 · Received December 9, 2004

    Report

    Report Number
    5101416
    Event Type
    Injury
    Date Received
    December 9, 2004
    Date of Event
    October 26, 2004
    Report Date
    December 8, 2004
    Manufacturer
    METRONIC, INC.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED AN ICD AT ANOTHER FACILITY IN (B)(6) 2003. ON (B)(6) 2004, PT REFERRED FOR ICD TESTING AFTER RECEIVING SEVERAL DISCHARGES. TESTING ON (B)(6) 2004 SHOWED PROBABLE MALFUNCTION. PT TAKEN TO EP LAB FOR FLUOROSCOPIC AND VISUAL EVAL OF THE UNIT AND LEADS. NO OBVIOUS PROBLEM IDENTIFIED AND IT WAS ASSUMED THAT THE PROBLEM WAS WITH THE INTERFACE BETWEEN THE VENTRICULAR LEAD AND THE DEVICE HEAD (SET SCREW), WHICH WAS TIGHTENED. POST EVAL TESTING COMPLETED. ON (B)(6) 2004, PT RE-ADMITTED WITH CONTINUED PROBLEMS WITH ICD DISCHARGES. PRE-INTERROGATION TESTING COMPLETED. THERE WAS TENTING OF CAN DURING REMOVAL OF DEVICE AT REMOVAL AND THE RV LEAD WAS FOUND TO HAVE VISIBLE DAMAGE OF THE PACED-SENSED PORTION OF THE TRIFURCATED ICD LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC IMPLANTABLE CARDIAC DEFIBRILLATOR NIK METRONIC, INC. 7274 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization