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

Model Number 2102

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Hematoma (1884); Unspecified Infection (1930)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was the external trauma in the device area.The device history record and sterilization record for these device serial 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.Cvrx id: (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.Shortly after implant, the patient sustained a trauma from their dog to the right chest wall overlying the ipg.The patient subsequently developed a subcutaneous hematoma and overlying erythema due to the external trauma.The patient was treated with antibiotics, and there was evidence of wound healing and apposition.On (b)(6) 2022, the patient presented with wound dehiscence and an exposed ipg.A pocket revision, irrigation, and debridement of right chest pocket was performed on (b)(6) 2022.Dissolvable antibiotic beads were also placed in the pocket though there was no evidence of malodor, purulence, or any other sign of pocket infection.It was noted that there had been poor incorporation of the device, and granulation tissue was observed throughout the wound bed.The device was repositioned in the subcutaneous pocket, and the patient was discharged on (b)(6) 2022.During a wound check on (b)(6) 2022, the patient presented with an infection including pain, fever, nausea, and redness at the ipg pocket.A ct showed minimal atelectasis and hypodense fluid surrounding the ipg.The ipg was explanted on (b)(6) 2022, and the csl was capped.Cultures were performed.Although the cultures were negative for infection, the physician stated there was an infection in the chest wall.In the opinion of the surgeon, the infection was related to poor pocket formation and ipg integration.In the opinion of the surgeon, the infection was related to poor pocket formation and ipg integration.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h10 cvrx id# (b)(6).

Event Description

A barostim system was implanted on (b)(6) 2022.Shortly after implant, the patient sustained a trauma from their dog to the right chest wall overlying the ipg.The patient subsequently developed a subcutaneous hematoma and overlying erythema due to the external trauma.The patient was treated with antibiotics, and there was evidence of wound healing and apposition.On (b)(6) 2022, the patient presented with wound dehiscence and an exposed ipg.A pocket revision, irrigation, and debridement of right chest pocket was performed on (b)(6) 2022.Dissolvable antibiotic beads were also placed in the pocket though there was no evidence of malodor, purulence, or any other sign of pocket infection.It was noted that there had been poor incorporation of the device, and granulation tissue was observed throughout the wound bed.The device was repositioned in the subcutaneous pocket, and the patient was discharged on (b)(6) 2022.During a wound check on (b)(6) 2022, the patient presented with an infection including pain, fever, nausea, and redness at the ipg pocket.A ct showed minimal atelectasis and hypodense fluid surrounding the ipg.The ipg was explanted on (b)(6) 2022, and the csl was capped.Cultures were performed.Although the cultures were negative for infection, the physician stated there was an infection in the chest wall.In the opinion of the surgeon, the infection was related to poor pocket formation and ipg integration.As of (b)(6) 2022, the infection had cleared, and the patient was doing well.

• 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: 15751669
• MDR Text Key: 303233695
• Report Number: 3007972010-2022-00018
• Device Sequence Number: 1
• Product Code: DSR
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 118 KG