BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 2131848 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00216
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S79
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. EVALUATION SUMMARY: (B)(4): THE MONITOR WAS ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT WHEN HE FINISHES THE READING PROCESS, AND THE FIFTH LIGHT LIGHTS UP, HE FEELS ELECTRICITY COME DOWN THE LINE TO THE PADDLE. HE STATED IT FEELS "LIKE BEING SHOCKED BY A 9 VOLT BATTERY." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT DXY MEDTRONIC MILACA INC. 2490G ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening 6932 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6932 IMPLANTABLE TACHY LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD