FDA Adverse Event
Injury
Summary report: N
INSPIRE
MDR report key: 7945197
·
Received October 8, 2018
Report
- Report Number
- 3007666314-2018-00042
- Event Type
- Injury
- Date Received
- October 8, 2018
- Date of Event
- October 2, 2018
- Report Date
- October 8, 2018
- Manufacturer
- INSPIRE MEDICAL SYSTEMS INC
- Product Code
- MNQ
- UDI-DI
- 10855728005496
- PMA / PMN Number
- P130008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE UNRELATED TO INSPIRE THERAPY THE SURGEON OBSERVED THAT THE SENSING LEAD, IMPLANTED 2.5 YEARS EARLIER, WAS PLACED IN THE PLEURAL SPACE. THERE IS NO PATIENT INJURY AND THE THERAPY IS WORKING WELL, BUT IT APPEARS THAT THE PATIENT EXPERIENCED A SELF HEALING PNEUMOTHORAX DURING THE IMPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786133 | INSPIRE | SENSING LEAD | MNQ | INSPIRE MEDICAL SYSTEMS INC | 4323 | 10855728005496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |