MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for INSPIRE MODEL 4063 STIMULATION LEAD 900-001-009 manufactured by Inspire Medical Systems.
[181088088]
Patient implanted (b)(6) 2020 presented to physician with a hematoma at the stimulation lead incision. The physician administered antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007666314-2020-00013 |
| MDR Report Key | 9753379 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-04 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-26 |
| 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 4063 STIMULATION LEAD |
| Generic Name | INSPIRE MODEL 4063 STIMULATION LEAD |
| Product Code | MNQ |
| Date Received | 2020-02-26 |
| Model Number | 4063 |
| Catalog Number | 900-001-009 |
| 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 | 2020-02-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-26 |