MAUDE Adverse Event Report: ACTEGY HEALTH INC REVITIVE MEDIC; STIMULATOR, MUSCLE, POWERED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Anxiety (2328); Numbness (2415)

Event Date 09/02/2018

Event Type  Injury  

Event Description

Reporter alleges used this device in the morning for about 3 minutes, starting with low stimulations and increasing stimulations gradually.After 3 minutes, she experienced shooting pain in her heart and turned off the device.She went to take a shower, whilst taking a shower she felt number at her left side and thought she was going to have a heart attack.Her daughter helped call 911.The paramedics came and accessed her by taking her vitals said she was fine and it was an anxiety/panic attack.The paramedics said she has tried to return the device.Reporter advised she has tried to return the device and spoke to the (b)(6).She is waiting for rma number to return the device.

• Brand Name: REVITIVE MEDIC
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): ACTEGY HEALTH INC
• MDR Report Key: 8366615
• MDR Text Key: 137252027
• Report Number: MW5084308
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 68