FDA Adverse Event
Injury
Summary report: N
INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
MDR report key: 12043082
·
Received June 22, 2021
Report
- Report Number
- 3007666314-2021-00084
- Event Type
- Injury
- Date Received
- June 22, 2021
- Date of Event
- June 16, 2021
- Report Date
- June 22, 2021
- Manufacturer
- INSPIRE MEDICAL SYSTEMS
- Product Code
- MNQ
- UDI-DI
- 10855728005632
- PMA / PMN Number
- P130008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IMMEDIATELY FOLLOWING IMPLANT PROCEDURE ON (B)(6) 2021, PATIENT COMPLAINED OF SHORTNESS OF BREATH. SURGEON ORDERED A CT SCAN AND FOUND THAT THE LEAD HAD PUSHED THROUGH THE PLEURA BY 2 INCHES. ON (B)(6) 2021, THE SURGEON BROUGHT THE PATIENT BACK INTO THE OR TO REPOSITION THE LEAD. NO PNEUMOTHORAX WAS NOTED AND THE PATIENT¿S ISSUE IS NOW RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 942176 | INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD | INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD | MNQ | INSPIRE MEDICAL SYSTEMS | 4340 | 10855728005632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |