BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M RED DOT ELECTRODES

    MDR report key: 996426 · Received November 9, 2007

    Report

    Report Number
    MW5005298
    Event Type
    Other
    Date Received
    November 9, 2007
    Report Date
    November 9, 2007
    Manufacturer
    3M
    Product Code
    DRX
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LETTER IS TO INFORM THE AGENCY THAT 3M MEDICAL DIVISION HAS RECEIVED AN UNUSUAL HIGH VOLUME OF COMPLAINTS OF SKIN IRRITATION/STRIPPING FROM CARDIONET IN REGARDS TO USING 3M RED DOT ELECTRODES IN COMBINATION WITH CARDIONET'S HOLTER MONITORING DEVICE. AFTER REVIEWING EACH COMPLAINT, NONE OF THE REPORTED INJURIES REQUIRE 3M TO FILE AN MDR PER FDA REG AND PER 3M SOP. THERE IS NO TREND INDICATING THAT THE INJURIES ARE CAUSED BY THE USE OF 3M ELECTRODES AS 3M SELLS OF ELECTRODES EACH YEAR AND HAS NO RECORD OF ANY SIMILAR INJURY REPORTED OTHER THAN THOSE ALL TIED TO CARDIONET. WE FEEL OBLIGATED TO ALERT THE AGENCY THAT A HIGH PERCENTAGE OF THE PTS MONITORED BY CARDIONET SYSTEM HAVE ALLEGED INJURY FROM THE PROCESS. IN MAY OF 2006, CARDIONET FILED SKIN IRRITATION COMPLAINTS ON 3M RED DOT 2271 & 2660 ELECTRODES. PRIOR TO THIS EVENT, THE 2271 & 2660 ELECTRODES GENERATED ABOUT 0.5 SKIN IRRITATION COMPLAINTS PER MONTH. DUE TO THIS INSIGNIFICANT JUMP IN COMPLAINTS, AN INTERNAL INVESTIGATION WAS STARTED TO DETERMINE THE POSSIBLE CAUSE. 3M WORKED WITH CARDIONET TO DETERMINE WHEN THE COMPLAINTS WERE OCCURRING AS WELL AS TO UNDERSTAND CARDIONET'S PROCEDURES AROUND HOW THEY ARE USING OUR ELECTRODES. 3M SUGGESTED CARDIONET TO USE 3M RED DOT 2560 & 2570 ELECTRODES IN LIEU OF THE 2660 ELECTRODE AS THE 2560 & 2570 ELECTRODES HAVE A LONGER WEAR TIME CLAIM. ADD'L RECOMMENDATIONS REGARDING SKIN PREPARATION WERE ALSO PROVIDED. IN MAY 2007, 3M RECEIVED 29 SKIN IRRITATION COMPLAINTS FROM CARDIONET ON THE 2570 ELECTRODE. PRIOR TO THIS, THE 2570 ELECTRODE HAD AVERAGED ABOUT 0.8 SKIN IRRITATIONS COMPLAINTS PER MONTH. ON JULY 18TH 3M WAS INFORMED OF ANOTHER COMPLAINTS. THE CAUSE FOR THESE COMPLAINTS CANNOT BE TRACED TO ANY DESIGN NOR MFG ISSUE. TESTING OF 2660 ELECTRODE RETAIN SAMPLES FROM THE COMPLAINT LOTS SHOWS THAT THE PRODUCT IS WITHIN ITS DESIGN SPECIFICATIONS. AS A PREVENTIVE ACTION TO MINIMIZE THE ADVERSE EVENTS CAUSED BY USING 3M RED DOT ELECTRODES IN COMBINATION WITH CARDIONET'S HOLTER DEVICE, 3M HAS STOPPED SELLING ELECTRODES TO CARDIONET. 3M WILL NOT RESUME THE BUSINESS WITH CARDIONET UNTIL A SATISFACTORY RESOLUTION TO THE PROBLEM CAN BE VERIFIED AND VALIDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M RED DOT ELECTRODES NONE DRX 3M 2271
    2 3M RED DOT ELECTRODES NONE DRX 3M 2260

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CARDIONET HOLTER MONITORING DEVICE