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 Code	Pocket Erosion (2013)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, based on the information received, it was suggested that the patient accumulated loose skin from the break-down of fat around the ipg pocket following weight loss which led to the ipg movement.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 or Problem Description
A barostim system was implanted on (b)(6) 2022.The patient reported that following weight loss, they have accumulated loose skin from the break-down of fat around the ipg pocket.The patient was noticing the ipg move when performing activities such as bending down, changing elevation level and while laying down to sleep.The patient felt the ipg was moving up to 180 degrees.The patient was advised to contact their care team.A pocket revision was approved and was successfully performed on (b)(6) 2024.The ipg was placed in an antibacterial pouch and anchored to the fascia.As of (b)(6) 2024, the patient reported that they were doing great.

• 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: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 19986512
• Report Number: 3007972010-2024-00049
• Device Sequence Number: 15254239
• Product Code: DSR
• UDI-Device Identifier: 00859144004210
• UDI-Public: (01)00859144004210(17)220528
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/28/2022
• 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: 07/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2020
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female