FDA Adverse Event
Injury
Summary report: N
ZEPHYR
MDR report key: 13252232
·
Received January 12, 2022
Report
- Report Number
- MW5106640
- Event Type
- Injury
- Date Received
- January 12, 2022
- Date of Event
- September 20, 2021
- Report Date
- December 10, 2021
- Manufacturer
- PULMONX, CORP.
- Product Code
- NJK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THREE (3) ZEPHYR VALVES (B)(6) 2021 WORSENING COPD, NEAR DEATH EXPERIENCE; FAILURE, VALVES REMOVED (2 OF 3) WITH SOME IMPROVEMENT OF COPD BUT REQUIRED ALMOST CONSTANT OXYGEN. HOSPITALIZED FOR 8 DAYS, MD'S COULDN'T GIVE ME ANSWERS. PULMONX COMPANY ZEPHYR VALVES MAKES NO MENTION OF LONG-TERM NEGATIVE EFFECTS. BETTER AFTER 2 OF 3 VALVES REMOVED. POST-OP IMPLANT ZEPHYR VALVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121597 | ZEPHYR | VALVE, PULMONARY | NJK | PULMONX, CORP. | NA | NA | |
| 121598 | ZEPHYR | VALVE, PULMONARY | NJK | PULMONX, CORP. | |||
| 121599 | ZEPHYR | VALVE, PULMONARY | NJK | PULMONX, CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Hospitalization | ASPIRIN| DULOXETINE| LIPITOR| MELATONIN| METFORMIN| PORTABLE OXYGEN.| TRELEGY| VITAMIN D3 |