BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1922040 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05843
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 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
    SD, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO STATE THAT HIS HEART RATE DROPPED BELOW 70 BEATS PER MINUTE FOR "SOME TIME" BEFORE GOING BACK UP TO 70 BEATS PER MINUTE. THE PATIENT ALSO REPORTED THAT HIS HEART WAS "SKIPPING BEATS". THE DEVICE REMAINS 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 5092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076