BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1925384 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06302
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 30, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THERE WAS SENSING DIFFICULTY AND OVERSENSING OF THE RIGHT VENTRICULAR LEAD. THE PHYSICIAN REMOVED THE LEAD TWICE AND RETIGHTENED THE SCREWS, BUT NOISE WAS SEEN. THE PHYSICIAN STATED THE SCREWS "NEVER FELT THEY TIGHTENED COMPLETELY." THE DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 6947 IMPLANTABLE TACHY LEAD