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

Model Number	2100
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Discomfort (2330)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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).
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h10 cvrx id# (b)(6).
Event or Problem 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
• Common Device Name: 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
• Report Number: 3007972010-2023-00009
• Device Sequence Number: 12750086
• Product Code: DSR
• UDI-Device Identifier: 00859144004210
• UDI-Public: (01)00859144004210(17)231006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female