BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2132042 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00244
    Event Type
    Malfunction
    Date Received
    June 16, 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
    MA, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): ANALYSIS COULD NOT CONFIRM THE INITIAL REPORT. HOWEVER ANALYSIS DID FIND CORROSION AND CONTAMINATION IN THE BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHEN THE BATTERIES WERE PUT INTO THE MONITOR, IT TURNED ON BY ITSELF AND BEEPED TWICE. WHILE THE PATIENT WAS READING THE INSTRUCTIONS, THE BATTERIES HEATED UP AND MELTED TO THE COVER OF THE BATTERY COMPARTMENT AND MELTED A PIECE OF PLASTIC THAT WAS UNDER THE MONITOR. THE PLASTIC WAS WATERY/WET. WHEN THE BATTERIES WERE REMOVED FROM THE MONITOR, THEY WERE EXTREMELY HOT. 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. 2490H ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other 4076 IMPLANTABLE PACING LEAD| BATTERIES PATIENT MONITORING ACCESSORY| 5076 IMPLANTABLE PACING LEAD| BATTERIES PATIENT MONITORING ACCESSORY| PHONECORD PATIENT MONITORING ACCESSORY| (B)(4) IMPLANTABLE PULSE GENERATOR| PHONECORD PATIENT MONITORING ACCESSORY