MAUDE Adverse Event Report: LIFEWATCH SERVICES, INC. ACT III SENSOR PLATINUM; DETECTOR AND ALARM, ARRHYTHMIA

Model Number DEV060

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Swollen Glands (2092); Loss of consciousness (2418)

Event Date 07/31/2014

Event Type  Injury  

Event Description

Patient stated that she has terrible allergy to nickel and had requested lifewatch to send sensitive electrodes.According to lifewatch recorded phone records from (b)(6) 2014, during the device shipment to the patient, it was not indicated that she was allergic to anything.Lifewatch mailed her the unit and she assumed that the electrodes sent were sensitive and non-nickel.She wore the monitor and had a terrible reaction, which caused her to have blisters and swollen throat.Patient mentioned she passed out an d could have did if it was not for her husband being a paramedic.Further, she stated that after she got discharged from the hosp she called lifewatch to get details and had a terrible experience with the customer service.According to her, a supervisor had called her back and told her lifewatch had no data and blamed her for not knowing the electrodes had nickel.However, lifewatch recorded the phone record does not verify patient's statement.

Manufacturer Narrative

The electrodes patient used had nickel as a component.The patient is allergic to nickel.Below is the product info for the electrode used by the patient: name: cleartrace electrode, supplier: conmed, supplier part number (b)(4).

• Brand Name: ACT III SENSOR PLATINUM
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): LIFEWATCH SERVICES, INC.; rosemont IL
• Manufacturer Contact: tina mansilla ; 10255 west higgins rd, st# 110; o'hare international center ii; rosemont, IL 60018 ; 8477202100
• MDR Report Key: 4102579
• MDR Text Key: 14878665
• Report Number: 3027765-2014-00001
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DEV060
• Device Catalogue Number: FG-00093
• Device Lot Number: K2025799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2014
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 57