BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2051718 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01544
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT IS OBSERVED ON (B)(6) 2011. THE IMPEDANCE BEHAVIOR CAN ALSO BE OBSERVED ON THE VPACE BI IMPEDANCE DAILY TREND, WHERE THE IMPEDANCE VALUE INCREASES FROM 589 OHMS ON (B)(6) 2011 TO 4047 OHMS ON THE (B)(6) 2011, WHERE IT REMAINS FOR THE REST OF THE RECORD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED, AND THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. THE PATIENT ALSO FELL GETTING OUT OF THE CAR. AN INTERROGATION SHOWED OVERSENSING, HIGH IMPEDANCE, AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED. UPON REVISION IT WAS FOUND THE SET SCREW WAS LOOSE. AFTER REPAIR, THE LEAD WAS TESTED AND FOUND TO BE WITHIN NORMAL TOLERANCES. THE DEVICE AND LEAD REMAIN 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 82 YR Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD