BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1922154 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05872
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    SC, 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 THE RIGHT ATRIAL LEAD FRACTURED. HIGH THRESHOLDS WERE OBSERVED ON BOTH THE RIGHT ATRIAL AND LEFT VENTRICULAR LEADS. THE RIGHT ATRIAL LEAD WAS CAPPED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE HAD LOWER LONGEVITY DUE TO HIGH OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. 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 58 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD