BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2204139 · Received August 11, 2011

    Report

    Report Number
    2183613-2011-00376
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 10, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S79
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE INCORRECT SUSPECT MEDICAL DEVICE WAS INADVERTENTLY REPORTED FOR THIS COMPLAINT UNDER MANUFACTURING REPORT NUMBER 2183613000-2011-00376-1 AND AS A RESULT THIS REPORT IS BEING REDACTED. THE CORRECT SUSPECT MEDICAL DEVICE FOR THIS REPORTABLE COMPLAINT WILL BE REPORTED UNDER A DIFFERENT MANUFACTURING REPORT NUMBER ACCORDINGLY.

    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

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE "INVALID DATA OBSERVATIONS" ON THE CARELINK REPORT. THE PRODUCT REMAINS IN USE. 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 53 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| 5092 IMPLANTABLE PACING LEAD| (B)(4) MOSAIC PORCINE HEART VALVE| 5092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) MOSAIC PORCINE HEART VALVE| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD