BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2131267 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03457
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 22, 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
    FL, 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. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE 1- PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 03:00:16. DAILY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR ATRIAL PACE BI IMPEDANCE= 798 TO 4047 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2011. SENSING - OVERSENSING 1 - VF=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 12:27:37.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GENERATOR CHANGEOUT THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. AT THE ONE DAY POST-OP CHECK, THE RIGHT ATRIAL (RA) LEAD DEMONSTRATED HIGH PACING THRESHOLDS AND HIGH IMPEDANCE. A CHEST X-RAY SUGGESTED THAT THE RA LEAD IS-1 PIN WAS NOT FULLY INSERTED INTO THE DEVICE HEADER BLOCK. A SURGERY WAS PERFORMED TO REINSERT THE RA LEAD PIN INTO THE DEVICE WHICH RESOLVED THE ISSUE. DURING THE SURGERY, IT WAS OBSERVED THAT THE LV LEAD PACING WAS RESULTING IN CAPTURE OF THE ATRIUM. THE LV LEAD PIN WAS RE-INSERTED INTO THE DEVICE HEADER BLOCK AND THE LV OUTPUT WAS PROGRAMMED OFF. THE RA LEAD AND THE DEVICE 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 37 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD