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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVRX, INC BAROSTIM NEO2; IMPLANTABLE PULSE GENERATOR
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CVRX, INC BAROSTIM NEO2; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number 2104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pocket Erosion (2013)
Event Date 01/02/2024
Event Type  Injury  
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).
 
Event Description
The patient was implanted on (b)(6) 2023 and had not experienced any adverse events due to an open pocket.The patient was responding well to therapy at their most recent titration visit.On (b)(6) 2023, it was reported that the patient's device pocket was open, and the patient was scheduled to have a pocket revision on (b)(6) 2023.On (b)(6) 2023, a pocket revision was done and although there were no visible signs of infection, the physician decided to explant the device.The pocket site was treated with antibiotics to minimize any chance of an infection.Antibiotics was also administered post pocket revision.The lead remained implanted, and the plan was to implant a new device in a few weeks when the site heals.The physician was unsure as to what the root cause of the pocket opening was.The surgical team closed the pocket, and the patient was sent to post anesthesia care unit after the revision.
 
Manufacturer Narrative
Updated fields: b4, b5, g1, g3, g6, h2, h10.Cvrx id# (b)(4).
 
Event Description
The patient was implanted on (b)(6) 2023 and had not experienced any adverse events due to an open pocket.The patient was responding well to therapy at their most recent titration visit.On (b)(6) 2023, it was reported that the patient's device pocket was open, and the patient was scheduled to have a pocket revision on (b)(6) 2023.On (b)(6) 2023, a pocket revision was done and although there were no visible signs of infection, the physician decided to explant the device.The pocket site was treated with antibiotics to minimize any chance of an infection.Antibiotics was also administered post pocket revision.The lead remained implanted, and the plan was to implant a new device in a few weeks when the site heals.The physician was unsure as to what the root cause of the pocket opening was.The surgical team closed the pocket, and the patient was sent to post anesthesia care unit after the revision.The patient was discharged.
 
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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 Key18623746
MDR Text Key334369808
Report Number3007972010-2023-00064
Device Sequence Number1
Product Code DSR
UDI-Device Identifier00859144004623
UDI-Public(01)00859144004623(17)241214
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number2104
Device Catalogue Number100065-202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age75 YR
Patient SexMale
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