MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO2; IMPLANTABLE PULSE GENERATOR

Model Number 2104

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Cardiogenic Shock (2262); Muscle/Tendon Damage (4532)

Event Date 03/30/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6)2023.On (b)(6) 2023, the patient was discharged and leaving for their car, felt unwell, and returned to the hospital.A hematoma was observed at the pocket, and the hematoma was evacuated.The patient's pectoral muscle was torn, and the root cause of the tear was unable to be determined, however, the muscle was reported to have been shredded where the ipg had been sutured.The ipg had moved from the chest pocket to the lateral side of the chest.A revision procedure was performed, and the ipg was placed back into the pocket.It was noted the ipg had still been connected to the lead.The ipg was interrogated, and it was functioning appropriately.The icd was also interrogated with no issues or interactions seen.The patient was in cardiogenic shock due to acute blood loss in the setting of heart failure and arrhythmias that were not picked up by the bi-v icd.The patient was subsequently placed on pressors, intubated, and sedated on an epinephrine drip.The patient was extubated on (b)(6) 2023 and weaned off the medications two days later.As of (b)(6) 2023, the patient was doing well and waiting for rehab placement.

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).

Manufacturer Narrative

Cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient was discharged and leaving for their car, felt unwell, and returned to the hospital.A hematoma was observed at the pocket, and the hematoma was evacuated.The patient's pectoral muscle was torn, and the root cause of the tear was unable to be determined, however, the muscle was reported to have been shredded where the ipg had been sutured.The ipg had moved from the chest pocket to the lateral side of the chest.A revision procedure was performed, and the ipg was placed back into the pocket.It was noted the ipg had still been connected to the lead.The ipg was interrogated, and it was functioning appropriately.The icd was also interrogated with no issues or interactions seen.The patient was in cardiogenic shock due to acute blood loss in the setting of heart failure and arrhythmias that were not picked up by the bi-v icd.The patient was subsequently placed on pressors, intubated, and sedated on an epinephrine drip.The patient was extubated on (b)(6) 2023 and weaned off the medications two days later.As of (b)(6) 2023, the patient was doing well and waiting for rehab placement.As of (b)(6) 2023 the patient had been discharged to rehab.A specific discharge date was not available.

• Brand Name: BAROSTIM NEO2
• 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: 16816647
• MDR Text Key: 314024460
• Report Number: 3007972010-2023-00013
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)241115
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 193 KG
• Patient Race: White