MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-20 for NEO LEGACY 2100 100053-301 manufactured by Cvrx, Inc..
[95371157]
A double lead repair was done at (b)(6) on (b)(6) 2017 during a normal ipg replacement. Ipg (b)(4) was replaced with (b)(4). The right lead was severed, and the terminal pin was missing, so that lead was fixed first. Dr. (b)(6) successfully repaired the lead resulting in an impedance of 349. Neo lead repair kit (b)(4) was used to repair the right lead. The outer coil on the left lead was stretched out between the terminal pin and tubing around the lead serial number label, but it still showed good connectivity with an impedance of 377. To reinforce this section of the lead, dr. (b)(6) put a tube around this portion and filled it with silicone adhesive. The final impedance for the left lead was 376. The patient had not been experiencing any symptoms leading up to the ipg replacement and lead repairs.
Patient Sequence No: 1, Text Type: D, B5
[118006499]
Evaluation of the returned device included the ipg (serial number (b)(4)) and part of the right lead (serial number (b)(4)). There were no anomalies found with the ipg, and it was functioning as intended when analyzed. The portion of the lead returned included a section with the serial number and a stretched out section of the coil. The lead was returned in two sections. The area of the lead that was fractured due to the design issue was not returned.
Patient Sequence No: 1, Text Type: N, H10
[118006500]
A double lead repair was done at (b)(6) on (b)(6) 2017 during a normal ipg replacement. Ipg (b)(4) was replaced with (b)(4). The right lead was severed, and the terminal pin was missing so that lead was fixed first. Dr. (b)(6) successfully repaired the lead resulting in an impedance of 349. Neo lead repair kit (b)(4) was used to repair the right lead. The outer coil on the left lead was stretched out between the terminal pin and tubing around the lead serial number label, but it still showed good connectivity with an impedance of 377. To reinforce this section of the lead, dr. (b)(6) put a tube around this portion and filled it with silicone adhesive. The final impedance for the left lead was 376. The patient had not been experiencing any symptoms leading up to the ipg replacement and lead repairs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2017-00003 |
| MDR Report Key | 7134425 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-20 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-10-30 |
| Device Manufacturer Date | 2015-12-18 |
| Date Added to Maude | 2017-12-20 |
| 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 | 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 | 2017-12-20 |
| Returned To Mfg | 2017-11-07 |
| Model Number | 2100 |
| Catalog Number | 100053-301 |
| Device Expiration Date | 2017-12-18 |
| 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 | 2017-12-20 |