BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2203108 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04306
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 31, 2011
    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
    OK, 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): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE WAS CONNECTED AND IMMEDIATELY NOTED OVERSENSING. SHAKING THE DEVICE AND LEAD MANIPULATION CAUSED OVERSENSING. LOSS OF CAPTURE AND SPIKING IMPEDANCES WERE ALSO NOTICED. THE DEVICE WAS DISCONNECTED AND TESTED THROUGH AN ANALYZER WHICH FOUND NOTHING WRONG. WHEN THE DEVICE WAS RECONNECTED TO THE PROGRAMMER THE PROBLEMS PERSISTED. THE TEST WAS REPEATED AT LEAST THREE TIMES, SUGGESTING POSSIBLE GROMMET DAMAGE. THE DOCTOR WAS DECIDED TO USE A NEW DEVICE. THE SECOND DEVICE WAS HOOKED UP AND OVERSENSING WAS NOTED FOR A FEW BEATS THEN NOTHING. THE IMPEDANCE MEASUREMENTS ON THE SECOND DEVICE WERE INITIALLY HIGH THEN STABILIZED. THE SECOND 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
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD