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

Model Number 2102

Device Problem Unintended Movement (3026)

Patient Problem Hematoma (1884)

Event Date 03/06/2023

Event Type  Injury  

Event Description

Barostim system was implanted on (b)(6) 2020.On (b)(6) 2023, it was reported that the ipg had migrated from the ipg to the breast level, the ipg was able to be turned within the pocket, and a hematoma was observed on the skin below the ipg pocket.The root cause of the hematoma was unable to be determined.The device pocket was opened on (b)(6)2023, and no signs of infection or bleeding was observed.The ipg was in the correct position in the pocket, and was still sutured with two sutures.The surgeon determined to leave the device as is, as the device was providing therapeutic effect.It was noted that the patient had lost weight.

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).

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2020.On (b)(6) 2023, it was reported that the ipg had migrated from the ipg to the breast level, the ipg was able to be turned within the pocket, and a hematoma was observed on the skin below the ipg pocket.The root cause of the hematoma was unable to be determined.The device pocket was opened on (b)(6)2023, and no signs of infection or bleeding was observed.The ipg was in the correct position in the pocket, and was still sutured with two sutures.The surgeon determined to leave the device as is, as the device was providing therapeutic effect.It was unknown why the ipg was reported to be moving even while still sutured, but it was noted that the patient had lost weight.As of on (b)(6) 2023, it was reported the patient recovered.

• 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: 16690301
• MDR Text Key: 312805930
• Report Number: 3007972010-2023-00008
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004005
• UDI-Public: (01)00859144004005(17)210723
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180050
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2021
• Device Model Number: 2102
• Device Catalogue Number: 100054-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White