ACTIHEART

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-10 for ACTIHEART manufactured by Unk.

Event Text Entries

[2792425] I am a pt participating in a medical study. The (b)(4) study at (b)(6) hospital. I was asked to wear the actiheart cardiac monitor with 3m red dot electrodes for 7 days. By the 4th day of wearing, i experienced breathlessness and tightness of the chest. I then got a persistent cough. By the 5th day, i began to get red skin at the point of contact and this got much worse quite rapidly. Nasty itching. I had been told by the study that the contact dermatitis was a possibility but the effect on my lungs, shortness of breath and coughing happened first and was more serious. I took the monitor off and felt a sense of instant relief, it had obviously put a load on my system. It is suggested that this is an allergy to the glue in the electrodes but i think it might be a reaction to the metals; i do experience redness of the skin if i wear cheap jewelry for a long period. I am a healthy individual. I suggest that this device is only suitable for use for 3 days maximum exposure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5026517
• MDR Report Key: 2702076
• Date Received: 2012-08-10
• Date of Report: 2012-08-10
• Date of Event: 2012-07-08
• Date Added to Maude: 2012-08-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ACTIHEART
• Generic Name: ACTIHEART CARDIAC MONITOR
• Product Code: MWJ
• Date Received: 2012-08-10
• Lot Number: UNK
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Device Sequence Number: 2

• Brand Name: 3M REDDOT
• Generic Name: ELECTRODE
• Product Code: DRX
• Date Received: 2012-08-10
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: 3M

Device Sequence Number: 3

• Brand Name: 3M REDDOT
• Generic Name: ELECTRODE
• Product Code: DRX
• Date Received: 2012-08-10
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: 3M

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-08-10