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

Model Number 2102

Device Problem Expulsion (2933)

Patient Problem Wound Dehiscence (1154)

Event Date 11/02/2023

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.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# (b)(4).

Event Description

A normal battery replacement occurred on (b)(6) 2023.Prior to the replacement, the lead impedance was 624-716 ohms.The newly implanted ipg had an impedance of 1400+ ohms, indicating an issue.The lead impedance was planned to be monitored, and an x-ray was suggested.No patient adverse event was reported.As of (b)(6) 2023, the patient was doing well and their blood pressure was as well controlled as before the replacement.On (b)(6) 2023, it was reported that the sutures had pulled out, and the ipg was externalized.Oral antibiotic treatment was started, and an ipg explant was planned for (b)(6) 2023.On (b)(6) 2023, the ipg was explanted and the patient was administered oral antibiotics.

• 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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 18243499
• MDR Text Key: 329433364
• Report Number: 3007972010-2023-00056
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004005
• UDI-Public: (01)00859144004005(17)241006
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P180050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2102
• Device Catalogue Number: 100054-201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White