REACTIV8
Report
- Report Number
- 3013017877-2024-00070
- Event Type
- Injury
- Date Received
- September 19, 2024
- Date of Event
- August 22, 2024
- Report Date
- November 2, 2024
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- UDI-DI
- 05391527770015
- PMA / PMN Number
- P190021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MML REFERENCE # (B)(4). NO ANOMALIES WERE OBSERVED ASSOCIATED WITH THE DEVICE DURING THE EVALUATION. THE IPG PASSED FUNCTIONAL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. BOTH LEADS WERE CUT DURING THE EXPLANT; THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED. THE VISUAL INSPECTION FOUND NO NON-CONFORMANCES ON BOTH LEADS. UPDATED H6.
MML REFERENCE # (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE REACTIV8 SYSTEM THREE WEEKS AFTER THE IMPLANT DUE TO A SUSPECTED WOUND INFECTION. THE DEVICE WAS REMOVED AND INTACT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. FURTHER INFORMATION WAS RECEIVED STATING THAT THE PATIENT DID NOT HAVE AN INFECTION BUT A WOUND-HEALING DISORDER ON BOTH SIDES DUE TO NICOTINE ADDICTION. WOUND SWAB RESULTS SHOWED NORMAL SKIN GERMS. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. ALTHOUGH REQUESTED, PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE ALLEGED WOULD HEALING ISSUE.
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE REACTIV8 SYSTEM THREE WEEKS AFTER THE IMPLANT DUE TO A SUSPECTED WOUND INFECTION. THE DEVICE WAS REMOVED AND INTACT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. FURTHER INFORMATION WAS RECEIVED STATING THAT THE PATIENT DID NOT HAVE AN INFECTION BUT A WOUND-HEALING DISORDER ON BOTH SIDES DUE TO NICOTINE ADDICTION. WOUND SWAB RESULTS SHOWED NORMAL SKIN GERMS. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. ALTHOUGH REQUESTED, PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE ALLEGED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2527808 | REACTIV8 | REACTIV8 SYSTEM | QLK | MAINSTAY MEDICAL LIMITED | 5100 / 8145 | 05391527770015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |