MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-09 for BAROSTIM NEO LEGACY 2100 100053-301 manufactured by Cvrx, Inc..
[102015213]
On approximately (b)(6) 2018, the patient spoke with (b)(6) at (b)(6) heart and complained of pain, thought the device had moved, and wanted to be seen. The patient is typically seen in (b)(6), but lives in (b)(6), so a follow-up was scheduled at (b)(6). On (b)(6) 2018, the patient was seen and was experiencing redness, skin erosion, possible infection, pain, swelling at the pocket. A replacement was scheduled for (b)(6) 2018. On (b)(46) 2018, the skin had been found to be eroded, and the ipg was explanted. The pocket was cultured and packed with iodoform gauze. The patient has a follow-up appointment on (b)(6) 2018. This event became reportable on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
[120865927]
On 28-mar-2018, it was reported the patient had a follow-up visit on (b)(6) 2018. The pocket was healing with no evident infection, but the leads were clearly protruding. The patient had an appointment on (b)(6) 2018 with the surgeon to discuss removing the leads up to the carotid region. It was noted that the patient's ipg had migrated to their anterior axilla causing pain and increasing tension on the leads. No additional information was provided regarding the migration. The patient was also prescribed an antibiotic, and wound service was ordered for their wound management. It was also reported the patient was placed on oral ciprofloxacin at 500mg on (b)(6) 2018. The patient had the leads completely removed on (b)(6) 2018, and the leads were sent to pathology. The pocket was also cultured again, the swabs were sent to pathology, and they returned with a stain for gram positive cocci and moderate growth of gram positive cocci in clusters. As of (b)(6) 2018, the patient was stable and recovering and will likely remain in the hospital at least through (b)(6) 2018. The patient stated they thought the issues had started around or shortly after (b)(6) 2017 with the pocket area looking bruised and feeling tender. They initially contacted (b)(6) worried that the device was not keeping their blood pressure under control and thought it may need to be checked. When the patient saw dr. (b)(6) in (b)(6) on (b)(6) 2018, most of the area over the device was bluish/purple and an area of the skin had opened.
Patient Sequence No: 1, Text Type: N, H10
[120865928]
On approximately (b)(6) 2018, the patient spoke with (b)(6) at (b)(6) and complained of pain, thought the device had moved, and wanted to be seen. The patient is typically seen in (b)(6), but lives in (b)(6), so a follow-up was scheduled at (b)(6). On (b)(6) 2018, the patient was seen and was experiencing redness, skin erosion, possible infection, pain, swelling at the pocket. A replacement was scheduled for (b)(46 2018. On (b)(6) 2018, the skin had been found to be eroded, and the ipg was explanted. The pocket was cultured and packed with iodoform gauze. The patient has a follow-up appointment on (b)(6) 2018. This event became reportable on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2018-00001 |
| MDR Report Key | 7327569 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-09 |
| Date of Report | 2018-06-18 |
| Date of Event | 2017-12-25 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2018-03-09 |
| 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 | MS. SARAH HICKS |
| Manufacturer Street | 9201 WEST BROADWAY AVENUE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 554451925 |
| Manufacturer Country | US |
| Manufacturer Postal | 554451925 |
| Manufacturer Phone | 7634162844 |
| Manufacturer G1 | CVRX, INC. |
| Manufacturer Street | 9201 WEST BROADWAY AVENUE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 554451925 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554451925 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAROSTIM NEO LEGACY |
| Generic Name | IMPLANTABLE PULSE GENERATOR |
| Product Code | DSR |
| Date Received | 2018-03-09 |
| Returned To Mfg | 2018-02-27 |
| Model Number | 2100 |
| Catalog Number | 100053-301 |
| Device Expiration Date | 2018-09-20 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CVRX, INC. |
| Manufacturer Address | 9201 WEST BROADWAY AVENUE SUITE 650 MINNEAPOLIS MN 554451925 US 554451925 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-09 |