MAUDE Adverse Event Report: BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. CARDIAC EVENT MONITORING (CEM) B; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 2285108

Patient Problems Superficial (First Degree) Burn (2685); Shock from Patient Lead(s) (3162)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

Patient states that her battery-operated 30-day event monitor she wore "electrocuted" her.Patient self reported the event and alerted to the possibility of small electrical burn to the chest area where the monitor was located.

• Brand Name: CARDIAC EVENT MONITORING (CEM) B
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
• MDR Report Key: 19033381
• MDR Text Key: 339384374
• Report Number: MW5153506
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2285108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White