BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1921578 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05800
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 7, 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
    WV, 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) NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN WAS UNABLE TO TIGHTEN DOWN THE SETSCREW OF THE DEVICE ON TO THE LEAD TERMINAL RESULTING IN A PACING IMPEDANCE OF GREATER THAN 3000 OHMS. MULTIPLE ATTEMPTS WERE MADE. THE DEVICE WAS REMOVED AND RETURNED AND A NEW DEVICE WAS SUCCESSFULLY 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 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other 5554 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD