BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNETIC DENTAL CHAIR

    MDR report key: 1351615 · Received March 23, 2009

    Report

    Report Number
    MW5010470
    Event Type
    Malfunction
    Date Received
    March 23, 2009
    Report Date
    March 23, 2009
    Manufacturer
    ADEC INC
    Product Code
    KLC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM A REGISTERED DENTAL HYGIENIST AND EDUCATOR. I TRAVEL AROUND THE COUNTRY DOING EDUCATIONAL PROGRAMS FOR DENTISTS AND DENTAL HYGIENISTS. IN DOING MY DUE DILIGENCE, I RECENTLY CAME ACROSS INFO THAT HAD NEVER BEEN DISCUSSED IN DENTISTRY, THAT COULD BE A POTENTIAL PROBLEM FOR PATIENTS WITH PACEMAKERS AND DEFIBRILLATORS. BOSTON SCIENTIFIC SENT ME A SHEET THAT THEY MAKE AVAILABLE TO DENTISTS AND PHYSICIANS TITLED "DENTAL EQUIPMENT AND IMPLANTABLE PACEMAKERS AND DEFIBRILLATORS" AND GIVES CONTRAINDICATIONS. THEY JUST ADDED A NEW ONE THAT HAS ME CONCERNED. THEY DISCUSS DENTAL CHAIRS WITH MAGNETIC HEADRESTS. I CONTACTED THE TOP 5 MANUFACTURER OF DENTAL CHAIRS, AND NONE OF THEM HAD ANY IDEA WHAT THE STRENGTH OF THEIR MAGNETS WERE. MIDMARK ACTUALLY DID SOME RESEARCH AND GOT BACK TO SAY THAT THEY HAD HEADREST. ACCORDING TO YOUR CARDIO DEPARTMENT, IT ONLY TAKES 6-10 GAUSS TO CONTROL THE DEVICE. MY REASON FOR LOOKING INTO THIS AND REPORTING THIS IS AFTER TALKING WITH RPTR, THOUGHT THAT THIS MIGHT BE THE BEST WAY TO SEE IF THERE ARE ANY INCIDENTS REPORTED THAT WOULD HAVE LEAD BOSTON SCIENTIFIC TO ADD THIS TO THEIR CONTRAINDICATIONS. AND IF THERE IS A CONCERN, I WOULD LIKE TO START EDUCATING DENTIST ANY HYGIENISTS ON THE POTENTIAL RISK. I APPRECIATE YOUR LOOKING INTO THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNETIC DENTAL CHAIR MAGNETIC DENTAL CHAIR KLC ADEC INC
    2 MAGNETIC DENTAL CHAIR MAGNETIC DENTAL CHAIR INN PELTON CRANE
    3 MAGNETIC DENTAL CHAIR MAGNETIC DENTAL CHAIR KLC MIDMARK
    4 MAGNETIC DENTAL CHAIR MAGNETIC DENTAL CHAIR KLC DENTAL-EZ
    5 MAGNETIC DENTAL CHAIR MAGNETIC DENTAL CHAIR KLC BELMONT
    6 BOSTON SCIENTIFIC PACEMAKERS DXY CONTRAINDICATION FOR DENTAL TREATMENT
    7 BOSTON SCIENTIFIC DEFIBRILLATORS LWS CONTRAINDICATION FOR DENTAL TREATMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other