BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2203644 · Received August 11, 2011

    Report

    Report Number
    2183613-2011-00373
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S102
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER STATED THAT SHE RECEIVED AN EMAIL NOTIFICATION INDICATING THAT THE PATIENT'S CARELINK TRANSMISSION HAD "FAILED." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER STATED THAT SHE RECEIVED AN EMAIL NOTIFICATION INDICATING THAT THE PATIENT'S CARELINK TRANSMISSION HAD "FAILED." ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SCHEDULED TRANSMISSIONS ARE BEING PROCESSED AS EXPECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE KRG MEDTRONIC MILACA, INC. 2490C ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD