MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR

Model Number 2102

Device Problems Unintended System Motion (1430); Insufficient Information (3190); Migration (4003)

Patient Problems Hematoma (1884); Loss of Range of Motion (2032); Neck Pain (2433)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Additional information has been requested from the site, and, if additional information is received, a supplemental report will be submitted.The device history records for the ipg and cslserial numbers have been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The devices met material, assembly, and quality control requirements.(b)(4).Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.During a follow-up appointment on (b)(6) 2022, the patient reported they experienced lead pulling and limited range of motion in their neck, which resulted in pain.The patient also experienced ipg movement in the chest.X-rays were performed, and nothing unusual was noted.A lead revision was performed on (b)(6) 2022.The physician opened the neck incision and observed the strain relief loop was in place.Additional lead was also pulled up from the pocket into the neck, and the procedure was completed.On (b)(6) 2022, the patient reported the issue was unchanged, and they still experienced lead pulling.The physician stated there was slack in the lead that was observed during the procedure.The physician recommended the patient stretch their neck regularly to manipulate the slack.On (b)(6) 2022, the patient performed some physical activity, and felt a pop in their neck.A small hematoma was observed near the incision site on (b)(6) 2022.The opinion of the physician was that an incision suture broke.

Manufacturer Narrative

The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the opinion of the physician was that the initial ipg pocket not being placed deep enough when taking into account the patient's weight contributed to the ipg movement and lead pulling in the neck.Note: the cvrx employee reported they were present at the procedure on (b)(6) 2022, and conversation on the importance of prompt event reporting has occurred.Cvrx id# (b)(4).

Event Description

On (b)(6) 2022, a revision was performed on the ipg pocket to make the pocket deeper, and it was noted the two ipg sutures were still intact.It was thought the surgeon had not taken into account the large size of the patient when placing the ipg, and made the pocket too shallow, which contributed to the movement and lead pulling.After the ipg revision, the placement of the ipg was improved, and the lead pulling in the neck was improved.It was noted that there was still minimal pulling, but no additional intervention was planned.No additional information was available on the hematoma.

• Brand Name: BAROSTIM NEO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 15262469
• MDR Text Key: 298283354
• Report Number: 3007972010-2022-00011
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female