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

Model Number 2100

Device Problem Unintended Movement (3026)

Patient Problems Wound Dehiscence (1154); Discomfort (2330)

Event Date 09/01/2022

Event Type  Injury  

Event Description

A normal ipg replacement occurred on (b)(6) 2022.The patient experienced the ipg shifting from side to side, and stated it was never comfortable since implant.A small opening was observed a week or two prior to (b)(6) 2023, but there were no signs of infection.In the opinion of the physician, the issue was related to the patient's low weight and breast implants not leaving enough tissue to protect the device, and the number of replacements was a possible contributing factor.A pocket revision occurred on (b)(6) 2023.The ipg was placed submuscularly, and the procedure went well.

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 related to the patient's low weight and breast implants not leaving enough tissue to protect the device with the number of replacements being a possible contributing factor.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

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

Event Description

A normal ipg replacement occurred on (b)(6) 2022.The patient experienced the ipg shifting from side to side, and stated it was never comfortable since implant.A small opening was observed a week or two prior to (b)(6) 2023, but there were no signs of infection.In the opinion of the physician, the issue was related to the patient's low weight and breast implants not leaving enough tissue to protect the device, and the number of replacements was a possible contributing factor.A pocket revision occurred on (b)(6) 2023.The ipg was placed submuscularly, and the procedure went well.As of (b)(6) 2023, the patient's wound was healed and there were no further concerns.

• Brand Name: BAROSTIM NEO LEGACY
• 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: 16725132
• MDR Text Key: 313143329
• Report Number: 3007972010-2023-00009
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004210
• UDI-Public: (01)00859144004210(17)231006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130007
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2023
• Device Model Number: 2100
• Device Catalogue Number: 100053-301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: 63 YR
• Patient Sex: Female