BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13CONSULTA

    MDR report key: 1874610 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05390
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE OF DEATH TO NOT APPLICABLE. 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. STD (SAVE TO DISK) REVIEW - NOT TESTED. STD FILE POSSIBLY CORRUPTED AND COULD NOT BE OPENED OR TRANSLATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEWLY IMPLANTED DEVICE WAS NOT PROVIDING ANY LEAD TREND DATA AND SHOWED HIGH LEAD IMPEDANCE ON PRINTOUT. HOWEVER, FOLLOW-UP THRESHOLD TESTS SHOWED THE LEAD TO HAVE NORMAL, ACCEPTABLE VALUES AND THAT THE LEAD WAS FUNCTIONING WELL. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE NEVER HAD THE DETECTIONS TURNED ON. NO TREND DATA IS COLLECTED UNTIL AFTER VF DETECTIONS HAVE BEEN TURNED ON FOR THE FIRST TIME. THE DEVICE PERFORMED AS DESIGNED AND IS STILL IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 13CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD