BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESYNC LEADWEAR

    MDR report key: 2228167 · Received January 9, 2009

    Report

    Report Number
    3003829651-2009-00009
    Event Type
    Other
    Date Received
    January 9, 2009
    Date of Event
    July 25, 2008
    Report Date
    January 8, 2009
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS NOT ASSOCIATED WITH A FAILURE OF THE LIFESYNC LEADWEAR TO MEET A SPECIFICATION OR USER REQUIREMENT. IN THIS CASE, A CARDIOLOGIST AT (B)(6) HOSP ALLEGED THAT THE OUTPUT OF THE ECG DATA USING LIFESYNC LEADWEAR IN ADDITION TO THE PT'S HISTORY OF HEART DISEASE AND APPARENT SYMPTOMS (CHEST PAINS) LED TO THE DETERMINATION THAT THE PT REQUIRED DIAGNOSTIC HEART CATHETERIZATION. FOLLOWING CATHETERIZATION, THE PT WAS NOTED TO HAVE PATENT "CLEAN" ARTERIES. UPON REQUEST BY LIFESYNC; OBJECTIVE EVIDENCE COULD NOT BE PROVIDED REGARDING THE ECG DATA THAT LED TO THE DIAGNOSTIC CATHETERIZATION. HOWEVER, CONVERSATION WITH THE NURSE MGR INDICATED THAT THE PT'S ECG HAD BEEN ANALYZED USING MASON-LIKAR LEAD PLACEMENT AS WELL AS STANDARD 12 LEAD DISTAL PLACEMENT. ACCORDING TO THE NURSE MGR, THE PT WAS ORDERED TO UNDERGO CATHETERIZATION REGARDLESS OF THE LEAD PLACEMENT USED TO OBTAIN THE ECG. NO HARM OCCURRED TO THE PT AS A RESULT OF THE CATHETERIZATION. THE (B)(6) LAB POLICY IS TO USE STANDARD 12 LEAD DISTAL LEAD PLACEMENT. LIFESYNC PRODUCT IS DESIGNED TO BE USED WITH MASON-LIKAR MODIFIED CHEST LEAD POSITIONS. STANDARD 12 LEAD DISTAL LEAD PLACEMENT AND MASON-LIKAR LEAD PLACEMENT HAVE SEVERAL KEY DIFFERENCES INHERENT TO EACH PLACEMENT METHOD THAT LEAD TO VARIATION BETWEEN ECG'S OBTAINED BY EITHER METHOD. AN ECG OBTAINED WITH MASON-LIKAR PLACEMENT SHOULD NOT BE INTERPRETED THE SAME AS AN ECG OBTAINED USING 12-LEAD DISTAL PLACEMENT. PRIOR TO THIS INCIDENT, LIFESYNC CORP PROVIDED APPLICATION NOTES AND PRODUCT LABELING TO ALL CUSTOMERS (INCLUDING (B)(6)) DETAILING THE DIFFERENCES BETWEEN MASON-LIKAR PLACEMENT AND STANDARD 12 LEAD DISTAL PLACEMENT AS WELL AS APPLICATION NOTES THAT PROVIDE INSTRUCTION FOR CONTINUOUS ST SEGMENT MONITORING USING MASON-LIKAR LEAD PLACEMENT. (B)(4).

    Description of Event or Problem · 1

    DR (B)(6), ALLEGED THAT THREE PTS UNNECESSARILY HAD DIAGNOSTIC HEART CATHETERIZATION PERFORMED DUE TO HIS INTERPRETATION OF ECG CHARTS OBTAINED THROUGH THE USE OF LIFESYNC CORP PRODUCT. INVESTIGATION OF THE INCIDENT DETERMINED THAT ONLY ONE PT WAS PRESCRIBED CATHETERIZATION THAT WAS SUBSEQUENTLY FOUND TO HAVE NO EVIDENCE OF BLOCKAGE. NO HARM TO THE PT WAS REPORTED. HOWEVER, THE MEDICAL DIRECTOR AT THE HOSP ALLEGED THAT THE PROCEDURE WAS UNNECESSARY AND INTRODUCED A HEALTH AND SAFETY RISK TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYNC LEADWEAR WIRELESS ECG SYSTEM DSA LIFESYNC CORPORATION LS-202 OR LS-203 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other