FDA Adverse Event
Injury
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 24161004
·
Received January 22, 2026
Report
- Report Number
- MW5182677
- Event Type
- Injury
- Date Received
- January 22, 2026
- Date of Event
- December 29, 2025
- Report Date
- January 16, 2026
- Manufacturer
- FLOWONIX MEDICAL, INC. / INFUSYN THERAPEUTICS.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
DESCRIPTION OF EVENT: INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING A 'PROGRAMMABLE PAIN PUMP'. PT STATED THEY WERE IMPLANTED SEVERAL YEARS AGO AND THEY HAVE 2 IMPLANTS. AGENT UNDERSTOOD PT HAS A NEVRO SCS DEVICE. PT STATED THEY 'THINK' THEY HAVE A MDT PAIN PUMP TOO. PT STATED THEY ARE GETTING A CODE ON THEIR REMOTE MACHINE. PT THEN STATED THEY HAVE FLOWONIX MEDICAL. PT STATED THEY WILL CONTACT THE APPROPRIATE COMPANY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219510 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | FLOWONIX MEDICAL, INC. / INFUSYN THERAPEUTICS. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | MDT PAIN PUMP AS CONCOMITANT DEVICES| SCS AND |