MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-14 for NEO LEGACY 2100 100053-301 manufactured by Cvrx, Inc..
[33401153]
Sterilization records of the ipg sterilization lot were reviewed and showed no issues with the sterilization process or acceptance. (b)(4). Based on these data, the infection rate is below that which might be expected.
Patient Sequence No: 1, Text Type: N, H10
[33401154]
Patient had ipg replaced on (b)(6) 2015. Patient was seen by his primary care physician on (b)(6) 2015 and the pocket was infected. Reported that the incision had opened up slightly and had pus coming from around the wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2015-00001 |
| MDR Report Key | 5292774 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-14 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-10-29 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 2015-01-27 |
| Date Added to Maude | 2015-12-14 |
| 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. AL CROUSE |
| Manufacturer Street | 9201 WEST BROADWAY AVENUE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 55445 |
| Manufacturer Country | US |
| Manufacturer Postal | 55445 |
| Manufacturer Phone | 7634167457 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO LEGACY |
| Generic Name | IMPLANTABLE PULSE GENERATOR |
| Product Code | DSR |
| Date Received | 2015-12-14 |
| Returned To Mfg | 2015-11-03 |
| Model Number | 2100 |
| Catalog Number | 100053-301 |
| Device Expiration Date | 2017-01-27 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CVRX, INC. |
| Manufacturer Address | 9201 WEST BROADWAY AVENUE SUITE 650 MINNEAPOLIS MN 55445 US 55445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-14 |