MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for BAROSTIM NEO LEGACY 2100 100053-301 manufactured by Cvrx, Inc..
[140285566]
Device showed high impedance on interrogation and patient was not getting adequate therapy as blood pressure was rising. It was expected that the lead insulation and conductors were potentially damaged as there have been multiple ipg replacements for this patient. A cvrx representative attended to surgical procedure and found that the lead was intact; however, there was some sort of contamination on the surface of the lead terminal pin that was interfering with making good contact with the ipg header and set screw. This contamination could not be removed by wiping the lead. It had to be scraped with a scalpel. Once cleared, the lead was reinserted into a new ipg and impedance readings were good again. Review of the returned ipg showed a contaminant in the ipg header bore; however, no clear analysis method was identified that was considered likely to identify the true cause of the high impedance. The new ipg and cleaned lead will be monitored for at least a month to determine if impedance is again high. If so, further action will need to be taken and it is likely that the lead terminal would be replaced with the cvrx lead repair kit and the lead terminal could be analyzed for source of the contamination more readily and easily than the existing header bore. No further analysis is planned if the impedance remains acceptable within this time period.
Patient Sequence No: 1, Text Type: N, H10
[140285567]
At a post ipg replacement follow-up on (b)(6) 2019, the lead impedance of the system varied between 1200 and 1700 ohms. It had been normal at approximately 600 ohms at the time of ipg replacement on (b)(6) 2018. Doctor chose to leave therapy on and have patient return to check in one month. Reported on (b)(6) 2019 that the patient stated blood pressure of 170s systolic and 100-120 diastolic and not in control and that the patient would like to do a lead repair. (b)(4) attended the surgery on (b)(6) 2019. This is where the event became reportable. In reviewing the situation in surgery, it was noted that there was contamination on the lead terminal pin that was the cause of the high impedance. No repair was required; however, the lead terminal pin could not be wiped clean and required scraping with a scalpel to remove the contamination. The ipg was replaced as there was also evidence of contamination in the header bore. It was unclear if the contamination was a bodily fluid that had dried on the surface or if it was potentially corrosion of the metals. The ipg was returned to cvrx for analysis. It was also reported that the surgeon used an antibacterial powder in the pocket at both surgeries that is believed to be vancomycin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2019-00001 |
| MDR Report Key | 8462137 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2019-03-28 |
| 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 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BAROSTIM NEO LEGACY |
| Generic Name | IMPLANTABLE PULSE GENERATOR |
| Product Code | DSR |
| Date Received | 2019-03-28 |
| Returned To Mfg | 2019-02-28 |
| Model Number | 2100 |
| Catalog Number | 100053-301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 55445 US 55445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-28 |