MAUDE Adverse Event Report: BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. MINI HEART MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 10/23/2023

Event Type  Injury  

Event Description

Patient called to report an adverse event involving her boston scientific mini heart monitor.Patient stated after about 2 weeks of use, she started itching under the pad.Patient stated she called the manufacturer and was sent another pad that was hypoallergenic.She said when she removed the old pad to put on the new pad, she noticed dried blood around the patch.Patient said she contacted the manufacturer and was told she would receive a call back and that she waited 3 days and never heard from anyone.Patient said she decided to take off the monitor herself because of the irritation and found bleeding sores under the patch with blood around the edges.Patient said her skin was raw and red.Reference report: mw5147890.

• Brand Name: MINI HEART MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
• MDR Report Key: 18092378
• MDR Text Key: 327865612
• Report Number: MW5147889
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female