BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2812075 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06638
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE ANALYSIS REVIEW FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE KEPT ABORTING THE LEFT VENTRICULAR CAPTURE MANAGEMENT TEST BECAUSE THE PROGRAMMED LEFT VENTRICULAR PULSE WIDTH WAS LESS THAN 0.4 MS. A REVIEW OF THE DEVICE PRODUCT PERFORMANCE INFORMATION INDICATED THAT THE CAPTURE MANAGEMENT TREND WAS DUE TO THE PULSE WIDTH BEING SET TOO HIGH WHEN IN FACT IT WAS THE OPPOSITE. THE 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 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD