MAUDE Adverse Event Report: CVRX, INC. BAROSTIM RHEOS; CAROTID SINUS LEAD

Model Number 1010L

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

The preliminary results of the investigation indicate the root cause of the event was a prior csl repair did not have a spot filled in with silicone leading to fluid ingress.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id# fc-000236.

Event Description

A normal ipg replacement was scheduled on (b)(6)2023.A previous lead repair, captured in cvrx complaint# 062, occurred in 2017.Left lead impedance had been turned off at some unknown time after the repair.On (b)(6), 2023, left lead impedance was activated, and initially, the lead passed compliance with an impedance of approximately 400.However, lead impedance then jumped to approximately 2500 and did not pass compliance.Attempts to activate impedance was made several times, but the issue recurred, and therapy was discontinued on the left lead.The ipg replacement was cancelled.An x-ray was performed, and both the right and left leads appeared damaged.However, lead impedance on the right lead remained acceptable and within compliance.It was noted that prior to bat therapy, the patient's blood pressure was greater than 300, and with therapy it was 180-200.Without the left lead activated, blood pressure was approximately 220-280.It was noted that the patient may not have been taking their medications.A procedure occurred on (b)(6), 2023.During the procedure, the ipg was replaced, and no visible damage or defects were observed on the right lead.However, at the point of the previous repair of the left lead, a spot was observed that that had not been filled with silicone during the repair that was filled with some liquid.An incision was made in the repair site, the fluid was drained, and the spot filled with silicone.Approximately 20 minutes after the procedure, the left lead impedance stabilized at 480 ohms.The procedure went well, and the patient was reported to be fine following the procedure.A follow-up was scheduled on (b)(6), 2023.

Event Description

A normal ipg replacement was scheduled for on (b)(6) 2023.A previous lead repair, captured in cvrx complaint#: (b)(4), occurred in 2017.Left lead impedance had been turned off at some unknown time after the repair.On (b)(6) 2023, left lead impedance was activated, and initially, the lead passed compliance with an impedance of approximately 400.However, lead impedance then jumped to approximately 2500 and did not pass compliance.Attempts to activate impedance was made several times, but the issue recurred, and therapy was discontinued on the left lead.The ipg replacement was cancelled.An x-ray was performed, and both the right and left leads appeared damaged.However, lead impedance on the right lead remained acceptable and within compliance.It was noted that prior to bat therapy, the patient's blood pressure was greater than 300, and with therapy it was 180-200.Without the left lead activated, blood pressure was approximately 220-280.It was noted that the patient may not have been taking their medications.A procedure occurred on (b)(6) 2023.During the procedure, the ipg was replaced, and no visible damage or defects were observed on the right lead.However, at the point of the previous repair of the left lead, a spot was observed that had not been filled with silicone during the repair that was filled with some liquid.An incision was made in the repair site, the fluid was drained, and the spot filled with silicone.Approximately 20 minutes after the procedure, the left lead impedance stabilized at 480 ohms.The procedure went well, and the patient was reported to be fine following the procedure.As of on (b)(6) 2023, the patient had recovered well.

Manufacturer Narrative

Cvrx id#: (b)(4).

• Brand Name: BAROSTIM RHEOS
• Type of Device: CAROTID SINUS LEAD
• 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: 17353721
• MDR Text Key: 319373886
• Report Number: 3007972010-2023-00032
• Device Sequence Number: 1
• Product Code: DSR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2011
• Device Model Number: 1010L
• Device Catalogue Number: 100008-203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2009
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 50 KG