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

Model Number 2102

Device Problem Unintended Movement (3026)

Patient Problem Implant Pain (4561)

Event Date 06/21/2018

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 barostim system was implanted on (b)(6), 2018.The patient reported experiencing discomfort and pain at both the ipg and csl locations and intermittent swelling at the csl electrode location since implant, but the symptoms had worsened.An x-ray was performed and no signs of infection were observed.However, the x-ray also showed the ipg looked to have migrated and was currently positioned at the level of the breast.It was unknown if the ipg was sutured with two sutures during the implant procedure.The surgeon planned to implant a new ipg on the opposite side.However, the patient developed covid, and the procedure was postponed.The patient was unresponsive to the clinic's attempts to bring them back which, in the opinion of the site, was related to the patient not wanting to be tested for medical compliance.A procedure occurred on (b)(6), 2023, and the system on the right side was explanted.It was found that the ipg had been sutured with two sutures, but the ipg had moved approximately 20 cm down from the initial pocket.It was observed that there were adhesions on the existing csl, and the csl was accidentally damaged when the surgeon tried to remove the adhesions.A lead repair was started, but the surgeon decided to cancel the repair and use a new csl.No lead repair parts remained in the patient.A new barostim system was implanted on the left side.A follow-up was scheduled for a few weeks.

Manufacturer Narrative

Cvrx id#: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2018.The patient reported experiencing discomfort and pain at both the ipg and csl locations and intermittent swelling at the csl electrode location since implant, but the symptoms had worsened.An x-ray was performed and no signs of infection were observed.However, the x-ray also showed the ipg looked to have migrated and was currently positioned at the level of the breast.It was unknown if the ipg was sutured with two sutures during the implant procedure.The surgeon planned to implant a new ipg on the opposite side.However, the patient developed covid, and the procedure was postponed.The patient was unresponsive to the clinic's attempts to bring them back which, in the opinion of the site, was related to the patient not wanting to be tested for medical compliance.A procedure occurred on (b)(6) 2023, and the system on the right side was explanted.It was found that the ipg had been sutured with two sutures, but the ipg had moved approximately 20 cm down from the initial pocket.It was observed that there were adhesions on the existing csl, and the csl was accidentally damaged when the surgeon tried to remove the adhesions.A lead repair was started, but the surgeon decided to cancel the repair and use a new csl.No lead repair parts remained in the patient.A new barostim system was implanted on the left side.As of on (b)(6) 2023, the patient was feeling well with no additional reported events.

• 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: 17370373
• MDR Text Key: 319485731
• Report Number: 3007972010-2023-00033
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004005
• UDI-Public: (01)00859144004005(17)200117
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2020
• 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: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic