MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-17 for NEO LEGACY 2100 100053-301 manufactured by Cvrx, Inc..
[72920054]
Surgeon discussed issue with patient and patient did not want device explanted, so surgeon agreed to attempt to place the device deeper under the skin and suture. Patient has been on antibiotics due to ongoing systemic infection. Patient will be monitored for signs of infection. On (b)(6) 2017, patient returned and showed signs of infection. Area was opened and showed large amount of pus that was cleaned and a system removal date has been scheduled for (b)(6) 2017. Device remains implanted at this time.
Patient Sequence No: 1, Text Type: N, H10
[72920055]
On (b)(6) 2017, (b)(6), a nurse at (b)(6), contacted cvrx to state that a portion of the right lead for the system was exposed. Cvrx had a call with the surgeon and recommended system removal. Patient did not wish to have the system removed and on (b)(6) 2017, a surgical procedure was performed to place the lead deeper under the skin.
Patient Sequence No: 1, Text Type: D, B5
[75741225]
Surgeon discussed issue with patient and patient did not want device explanted, so surgeon agreed to attempt to place the device deeper under the skin and suture. Patient has been on antibiotics due to ongoing systemic infection. Patient will be monitored for signs of infection. On (b)(6) 2017, patient returned and showed signs of a possible infection. Area was opened and showed large amount of pus that was cleaned, a sample was sent to be cultured, and a system removal date was scheduled for (b)(6) 2017. A call was received from (b)(6) on (b)(6) 2017 that the patient had returned for a pre-operative check to assess the situation and whether the patient was healthy enough for the removal surgery. At this visit, the culture results were reviewed and showed negative for any signs of infection. In addition, the site looked much better with no signs of swelling, redness or drainage. The determination was made to leave the device implanted as the recovery seemed to be going well. The patient has continued to get good therapy from the system throughout this event. Device remains implanted at this time.
Patient Sequence No: 1, Text Type: N, H10
[75741226]
On (b)(6) 2017, (b)(6), a nurse at (b)(6), contacted cvrx to state that a portion of the right lead for the system was exposed. Cvrx had a call with the surgeon and recommended system removal. Patient did not wish to have the system removed and on (b)(6) 2017, a surgical procedure was performed to place the lead deeper under the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2017-00002 |
| MDR Report Key | 6497329 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-17 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-03-17 |
| Device Manufacturer Date | 2012-08-27 |
| Date Added to Maude | 2017-04-17 |
| 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 |
| Manufacturer G1 | CVRX, INC. |
| Manufacturer Street | 9201 WEST BROADWAY AVENUE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 55445 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55445 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2017-04-17 |
| Model Number | 2100 |
| Catalog Number | 100053-301 |
| Device Expiration Date | 2014-08-27 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2017-04-17 |