FDA Adverse Event
Injury
Summary report: N
REACTIV8
MDR report key: 23159404
·
Received September 26, 2025
Report
- Report Number
- 3021520203-2025-00036
- Event Type
- Injury
- Date Received
- September 26, 2025
- Date of Event
- December 6, 2024
- Report Date
- September 26, 2025
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- PMA / PMN Number
- P190021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MML# (B)(4). NO PATIENT DEMOGRAPHIC INFORMATION AVAILABLE.
Description of Event or Problem · 0
MAINSTAY MEDICAL LIMITED (MML) RECEIVED INFORMATION THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE DUE TO POCKET SITE PAIN. MAINSTAY WAS UNABLE TO GET MORE INFORMATION ABOUT THIS EVENT. THE IPG WAS LATER EXPLANTED DUE TO POCKET SITE PAIN. NO MML REPRESENTATIVE WAS PRESENT FOR THESE EVENTS AND WAS ONLY NOTIFIED AFTER THE EXPLANT PROCEDURE. REFERENCE MML MFG REPORT NUMBER: 3021520203-2025-00083 FOR THE EXPLANT PROCEDURE. THE DEVICE HISTORY RECORD WAS PERFORMED. NO RELEVANT NONCONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE PAIN EXPERIENCED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317067 | REACTIV8 | REACTIV8 IMPLANTABLE PULSE GENERATOR | QLK | MAINSTAY MEDICAL LIMITED | 5100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |