MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for REVITIVE MEDIC manufactured by Actegy Health Inc.
[137252027]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084308 |
| MDR Report Key | 8366615 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-09-02 |
| Date Added to Maude | 2019-02-25 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REVITIVE MEDIC |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2019-02-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTEGY HEALTH INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-22 |