FDA Adverse Event
Malfunction
Summary report: N
INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
MDR report key: 12042846
·
Received June 22, 2021
Report
- Report Number
- 3007666314-2021-00081
- Event Type
- Malfunction
- Date Received
- June 22, 2021
- Date of Event
- June 4, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AT THE TIME OF THE SURGERY (B)(6) 2021, THE INSPIRE SENSE LEAD WAS REMOVED AND REPLACED DUE TO LACK OF EFFICACY OF THE THERAPY. DURING THE REMOVAL PROCEDURE, THE SENSOR LEAD WAS FOUND TO HAVE SEPARATED FROM THE LEAD BODY AND TO HAVE MIGRATED 5 CM. THE PHYSICIAN REMOVED THE SENSOR LEAD USING CT IMAGING. THE REVISION SURGERY ADDRESSED THE RISK AND THE ISSUE IS NOW RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940161 | 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 |