BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1792679 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03158
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IT SHOWED INTERFERENCE/NOISE. ADDITIONALLY, THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 1318 AND THE RATE OF ACCUMULATION HAS BEEN STEADY. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    REVIEW OF DEVICE DATA VIA SAVE-TO-DISK SHOWED THERE WAS POSSIBLE OVERSENSING. THE RV LEAD WAS A COMPETITIVE PRODUCT. FURTHER REVIEW OF DEVICE DATA REVEALED INTERFERENCE/NOISE AND THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER WAS HIGH, INDICATING A POSSIBLE INTERMITTENCY IN THE SYSTEM. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 4196 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| SP02 NON-MEDTRONIC IMPLANTABLE TACHY LEAD