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..
[72920716]
Patient noticed what seemed like a small portion of their lead trying to erode through their skin. The patient experienced "shock like" pains if the area was touched. The patient was seen on (b)(6) 2017, and had been experiencing their symptoms for several weeks prior. The surgeon, dr. (b)(6) examined the patient and reviewed an x-ray of the area. The x-ray showed what appeared to be a small portion of a lead wire without insulation. The location was proximal to the device and appeared to be the non-working left lead. A lead repair had been attempted several years previously on the left lead, however, no information was known about the repair. The patient was getting a good response from the therapy being delivered on the right lead only and impedance of this lead was good. Dr. (b)(6) wanted to remove the damaged part of the left lead without disturbing the ipg as it still had 18 months of battery life. The revision was performed on (b)(6) 2017 without incident. The damaged section of the left lead was actually inside the previously repaired area and not exposed outside the body. Dr. (b)(6) thought the additional material required for the repair was rubbing against the patient's very thin skin and causing discomfort. The damaged section was removed, and they reported it would be returned to cvrx. The remaining right lead had good impedance during and after the procedure and the neo legacy ipg was working properly. The patient has completely recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2017-00001 |
| MDR Report Key | 6496869 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-17 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-21 |
| Device Manufacturer Date | 2014-04-02 |
| 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 | 0 |
| 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 AVE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 554451925 |
| Manufacturer Country | US |
| Manufacturer Postal | 554451925 |
| Manufacturer Phone | 7634167457 |
| 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 | 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 | 2016-04-02 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 554451925 US 554451925 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-17 |