FDA Adverse Event
Injury
Summary report: Y
INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
MDR report key: 11603524
·
Received April 1, 2021
Report
- Report Number
- 3007666314-2021-00031
- Event Type
- Injury
- Date Received
- April 1, 2021
- Date of Event
- March 4, 2021
- Report Date
- April 1, 2021
- Manufacturer
- INSPIRE MEDICAL SYSTEMS
- Product Code
- MNQ
- UDI-DI
- 10855728005632
- PMA / PMN Number
- P130008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT PRESENTED TO PHYSICIAN WITH SENSE LEAD PROTRUDING FROM THE INCISION SITE. PHYSICIAN PRESCRIBED IV ANTIBIOTICS TO TREAT STAPH INFECTION AND THE WHOLE SYSTEM WAS EXPLANTED TO TREAT THE INFECTION ON (B)(6) 2021, RESOLVING THE PATIENT¿S ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498208 | 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 |