BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2127598 · Received June 15, 2011

    Report

    Report Number
    6000144-2011-02973
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 1, 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
    PA, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ALERT - LEAD INTEGRITY ALERT TRIGGERED 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4)-2011 15:32:26. SENSING - OVERSENSING 11- VENTRICULAR NST<=210 MS AVERAGE V-CYCLE BETWEEN (B)(4)-2011 11:30:44 AND (B)(4)-2011 15:38:42. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=5.4 COUNTS AVG/DAY, IN 8.31 DAYS, BETWEEN (B)(4)-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE ELECTROGRAM THAT COULD POSSIBLY BE DUE TO ELECTROMAGNETIC INTERFERENCE. IT WAS ALSO REPORTED THAT THERE WERE MULTIPLE NON-SUSTAINED VENTRICULAR TACHYCARDIAS DUE TO OVERSENSING AND THE LEAD INTEGRITY ALERT HAD TRIGGERED. THE DEVICE IS STILL 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 60 YR Other 6725 ADAPTOR| 1156T COMPETITOR IMPLANTABLE PACING LEAD| SPO2 COMPETITOR IMPLANTABLE TACHY LEAD