MAUDE Adverse Event Report: CARDIONET / LIFEWATCH / BIOTELEMETRY, INC. BIOTEL HEART MONITOR DEVICE; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/01/2018

Event Type  Injury  

Event Description

I was received a heart monitor device from biotel, the leads they sent were not compatible for my skin.I notified the company and was offered no resolution but mailed a bill when i returned the defective medical device.

• Brand Name: BIOTEL HEART MONITOR DEVICE
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): CARDIONET / LIFEWATCH / BIOTELEMETRY, INC.
• MDR Report Key: 7681217
• MDR Text Key: 113907567
• Report Number: MW5078331
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/09/2018
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 75