MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-29 for INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD 900-009-002 manufactured by Inspire Medical Systems.
[176846959]
While placing the 4340 sensing lead, the surgeon observed air escape which could audibly be heard with ventilation and verified when bubbles were seen when the surgical pocket was filled with saline. A chest tube was placed to address the pneumothorax. The issue was resolved and the chest tube was removed the day after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007666314-2020-00001 |
| MDR Report Key | 9641931 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-12-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOEL AABERG |
| Manufacturer Street | 5500 WAYZATA BLVD. SUITE 1600 |
| Manufacturer City | GOLDEN VALLEY MN 55416 |
| Manufacturer Country | US |
| Manufacturer Postal | 55416 |
| Manufacturer Phone | 7632057970 |
| Manufacturer G1 | INSPIRE MEDICAL SYSTEMS |
| Manufacturer Street | 5500 WAYZATA BLVD. SUITE 1600 |
| Manufacturer City | GOLDEN VALLEY MN 55416 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55416 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD |
| Generic Name | INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD |
| Product Code | MNQ |
| Date Received | 2020-01-29 |
| Model Number | 4340 |
| Catalog Number | 900-009-002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSPIRE MEDICAL SYSTEMS |
| Manufacturer Address | 5500 WAYZATA BLVD. SUITE 1600 GOLDEN VALLEY MN 55416 US 55416 |
| Product Code | --- |
| Date Received | 2020-01-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-29 |