MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC ACT 3: BRIGADIER

Model Number	ACT 3: BRIGADIER
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Braemar manufacturing, llc have not received the affected device back for evaluation at the time of this submission.The affected device has not been returned by the patient.No additional information is known to braemar manufacturing, llc at this time.
Event or Problem Description
On (b)(6) 2019, the initial reported (patient) notified lifewatch services, llc ((b)(4)) that the "device shocked me in the middle of my heart".The patient indicated that the shock sensation was coming from the electrodes.The patient did not seek medical attention for the alleged event.
Event or Problem Description
On 22-may-2019, the initial reporter (patient) notified (b)(6) that the "device shocked me in the middle of my heart".The patient indicated that the shock sensation was coming from the electrodes.The patient did not seek medical attention for the alleged event.Note: braemar manufacturing, llc become aware date is 30-may-2019.
Additional Manufacturer Narrative
The patient described that the device shocked her in the middle of her heart, specifically the electrodes.Based on the reported allegation of "patient felt shock in the middle of heart" was assessed by a health professional and was reported to fda due to patient's subjective claim of serious injury.The patient did not seek any medical attention associated with the reported allegation.A replacement device was sent and the patient continued the service with no further problems.The patient has not returned the device associated with the allegation.The device history record was reviewed, with no contributing factors identified.There are no reports of previous allegations similar to the one associated with this case documented on file.No additional information is known to braemar manufacturing, llc at this time.
Event or Problem Description
On (b)(6) 2019, the initial reporter reported (patient) notified (b)(4), llc (registration number 3027765) that the "device shocked me in the middle of my heart".The patient indicated that the shock sensation was coming from the electrodes.The patient did not seek medical attention for the alleged event.Note: the braemar manufacturing, llc become aware date is 30-may-2019.

• Brand Name: ACT 3: BRIGADIER
• Common Device Name: ACT 3: BRIGADIER
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan, mn MN 55121
• MDR Report Key: 8727309
• Report Number: 2133409-2019-00005
• Device Sequence Number: 1729739
• Product Code: DSI
• UDI-Device Identifier: 00850725007026
• UDI-Public: 00850725007026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: ACT 3: BRIGADIER
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 05/30/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 06/25/2019; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR